survey men

Clinical studies/trials are important in finding more and better treatments. Participation in clinical studies or trials offers one way to help advance research into gastrointestinal (GI) disorders. Here is a list of clinical studies, in adults and children, that are seeking participants. A description of the study purpose and contact information is included.

Research Highlighted in the October Digestive Health Monthly eNewsletter

COVID-19

 

The Impact of the Coronavirus (COVID-19) Pandemic on Gastrointestinal Symptoms and Well-Being: An International Collaborative Study

Purpose of study: The purpose of this study is to better understand the impact of the Coronavirus (COVID-19) pandemic for those living with a gastrointestinal condition. Specifically, this study will explore the pre-COVID-19 and current perceived impact of this pandemic on gastrointestinal symptoms, gastrointestinal condition management, fears relating to COVID-19, COVID-19 and gastroenterological condition illness perceptions, psychological distress, catastrophizing, coping and acceptance strategies, and quality of life. The study will also explore potential changes to condition management, fears relating to COVID-19, psychological distress, coping, and quality of life in 6 and 12 months after initially completing the baseline questionnaire.

Sponsor: An international collaboration of researchers who work to understand the interrelationships between psychological and gastrointestinal well-being.

Participation: Any GI condition including DGBI. Individuals living with a gastrointestinal condition age 18 or older who can read and write English.

Contact: For more information, visit https://www.gicovid19study.com/ or Simon Knowles, PhD This email address is being protected from spambots. You need JavaScript enabled to view it..

Added June 2020

 

Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: a Randomized, Double-blind, Placebo-Controlled Phase 2a Study, in Adult Subjects Hospitalized With SARS-CoV-2 Positive Pneumonia (NCT04414618)

Purpose of study: Treatment of SARS-CoV-2 Positive Pneumonia

Sponsor: RedHill Biopharma

Participation:

1. Adult male or female ≥18 to ≤80 years of age
2. Proven COVID-19 infection per RT-PCR assay of a pharyngeal sample (nasopharyngeal or oropharyngeal) AND pneumonia defined as radiographic opacities on chest X-ray
3. The patient requires supplemental oxygen at baseline
4. The patient, guardian or legal representative has signed a written IRB-approved informed consent

Contact: For more information, contact Mark L Levitt, MD, PhD+972-3-541-3131 Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Added July 2020

Copy of ClinTrial NIH COVID

Purpose of study: The novel coronavirus pandemic is impacting people with rare diseases and their families. Those impacts can be related to physical health, emotional health, availability of supplies, access to care, or other problems. Your responses may help researchers understand the impacts of COVID-19 on the rare disease community.

Sponsor: NIH

Participation: You qualify for this study if you or someone you care for has been diagnosed with a rare disease, is 0 to 89 years old, and currently lives in the United States. 

A rare disease is defined as a condition that affects fewer than 200,000 people. The NIH’s NCATS Genetic and Rare Diseases Information Center (GARD) offers information on nearly 7,000 rare diseases.

About the study: 

You will be asked to share your experience by completing our survey. Some things we hope to learn:

• Who is becoming infected?
• Where do they live?
• What symptoms are they seeing?
• What treatments are they receiving?
• How is access to care changing?
• Are patients able to obtain needed medical and nutritional supplies?
• How are stress and anxiety impacting patients and families?

Contact: For more information, visit RareDiseasesNetwork.org/COVIDsurvey. Email the study team at This email address is being protected from spambots. You need JavaScript enabled to view it.

Survey link to Spanish version: https://www.rarediseasesnetwork.org/encuestacovid

Added June 2020

 

All Functional GI Disorders

ClinTrial NIH Cancer and chronic illness

Purpose of study: The National Institute of Nursing Research (NINR), at the National Institutes of Health (NIH) is seeking people who are cancer survivors or have a chronic illness such as myalgic encephalomyelitis (ME), chronic fatigue syndrome (CFS), Sjogren’s disease, or Lupus to participate in a research study on fatigue. Fatigue is a common side effect of various illnesses. Researchers want to test if a one-time dose of the medication Ketamine or a similar drug can reduce fatigue. This is not a treatment study for fatigue, cancer, ME, CFS, Sjogren’s disease, or Lupus. Study procedures and medications are provided at no cost. Travel costs for study visits will be reimbursed in accordance with NIH guidelines.

Sponsor: National Institutes of Health (NIH) 

Participation:

You may participate if you:
• Are at least 18 years old
• Have experienced fatigue for at least 6 months
• Are in cancer remission or have a diagnosis of ME, CFS, Sjogren’s disease, or Lupus
You may NOT participate if you:
• Have HIV, Hepatitis B, or C
• Have post-traumatic stress disorder (PTSD) or a traumatic brain injury
• Are pregnant or nursing
*Please note that NINR employees/staff or their immediate family members are not eligible to participate.

About the study: 

• 9 visits to the NIH Clinical Center and 3 follow-up phone calls
• You will receive doses of Ketamine and an active drug (active placebo)
• You will complete questionnaires, assessments, and give blood samples
• This is an outpatient study that may last approximately one month

Contact:

NIH Clinical Center Office of Patient Recruitment
866-444-1132
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Added June 2020

ClinTrial Alcohol

Purpose of study: An increasing body of preclinical literature suggests a role of the gut microbiota in a wide range of medical disorders, including neuropsychiatric diseases like autism, anxiety, and depression. Preliminary studies have reported alterations in microbiota composition, inflammation, and intestinal permeability in alcohol-dependent patients. However, there is little research on the association between these alterations and behavioral outcomes associated with alcohol use disorder (AUD), such as alcohol craving and drinking. The main goal is to investigate gut microbiota differences in current drinking versus abstinent individuals with AUD, and whether microbial profiles are correlated with alcohol cue-induced craving. Finally, another goal of this project will be to conduct preliminary translational bed-to-bench work using rodent models of excessive alcohol use via collaborations with basic science laboratories.

Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Participation: 

Current Alcohol Use Disorder (AUD) by DSM-5 criteria
Being alcohol abstinent for at least 4 weeks, with a minimum of 2 weeks in a non-protective environment at the time of study screening.
Specific For Current Drinking Group; CD

Current Alcohol Use Disorder (AUD) by DSM-5 criteria
Participants not seeking treatment for their alcohol use will be included.
Satisfying heavy drinking criteria during the 4-weeks prior to screening (i.e., for men, >14 standard drinks in any one week or greater than or equal to 4 drinks per occasion at least once per month over the past 30 days; for women, >7 drinks per week or greater than or equal to 3 drinks per occasion at least at least once per month over the past 30 days) and any drinking during the 2-day prior to signing the study-specific consent.
Specific For Healthy Control Group; HC

No current or past diagnostic of AUD by DSM-5 criteria
Moderate alcohol consumers: i.e., up to 1 drink per day on average and not meeting NIAAA criteria for:
-heavy (i.e., for men, >14 standard drinks in any one week or greater than or equal to 4 drinks per occasion at least once per month over the past 30 days; for women, >7 drinks per week or greater than or equal to 3 drinks per occasion at least at least once per month over the past 30 days)
-or binge drinking (i.e., drinking 5 or more standard drinks on the same occasion on at least 1 day in the past 30 days for both male and female)
If any answer is No , subject may not be enrolled.

Contact: Lisa A Farinelli, R.N.(301) 496-0836 This email address is being protected from spambots. You need JavaScript enabled to view it. ClinicalTrials.gov Identifier: NCT03152760

Added January 2020

 

ClinTrial Omalizumab

Purpose of study: Participants sought for inclusion in a registry of individuals with functional GI disorders, in order to acquire a pool of individuals for contact for future studies.

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Participation: Individuals who meet all of the following criteria are eligible for enrollment as study participants:

Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable;
Peanut allergic: participant must meet all of the following criteria to minimize the chance that the participant will develop natural tolerance to peanut over the course of the study:

Positive skin prick test (SPT) defined as ≥4 mm wheal greater than saline control) to peanut,
Positive peanut immunoglobulin E (IgE), ≥6 kUA/L, at Screening or within three months of Screening, determined by ImmunoCap, and
Positive double-blind placebo-controlled food challenge (DBPCFC), defined as experiencing dose-limiting symptoms at a single dose of ≤100 mg of peanut protein.
Allergic to at least two of the six other foods (milk, egg, wheat, cashew, hazelnut, walnut): each participant must meet all of the following criteria for at least two of the six other foods to minimize the chance that the participant will develop natural tolerance to at least two of the six other foods over the course of the study:

Positive SPT (≥4 mm wheal) to food,
Positive food specific IgE (≥6 kUA/L) at Screening or within three months of Screening, determined by ImmunoCap, and
Positive DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg of food protein.
With body weight (as measured at Screening) and total serum IgE level (as measured within three months of Screening) suitable for omalizumab dosing;
If female of child-bearing potential, must have a negative urine or serum pregnancy test;
For women of childbearing potential, must agree to: remain abstinent (refrain from heterosexual intercourse), use acceptable contraceptive methods (barrier methods, oral, injected, or implanted hormonal methods of contraception, or other forms of hormonal contraception that have comparable efficacy), during the treatment period and for 60 days after the last dose of study drug.

Plan to remain in the study area of a Consortium for Food Allergy Research (CoFAR) clinical research unit (CRU) during the trial; and
Be willing to be trained on the proper use of the Epinephrine Autoinjector.

About the study: This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 2 to less than 56 years of age who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may be allergic to more than two other foods, the primary endpoint/outcome in this study will only be assessed in peanut and two other foods for each participant. The primary objective of the study is to compare the ability to consume foods without dose-limiting symptoms during a double-blind placebo-controlled food challenge (DBPCFC), after treatment with either omalizumab or placebo for omalizumab.

Contact: For more information, visit https://www.nih.gov/ or https://clinicaltrials.gov/.

Added August 2019

 

Online Registry of Individuals with a Functional GI Disorder 

Purpose of study: Participants sought for inclusion in a registry of individuals with functional GI disorders, in order to acquire a pool of individuals for contact for future studies.

Sponsor: Macquarie University, Australia

Participation: Any individual with a functional GI disorder and some level of abdominal discomfort is invited to participate.

About the study: Individuals included in the registry may be invited to participate in future research studies conducted by online questionnaire.

Contact: For more information, visit www.mqedu.qualtrics.com or This email address is being protected from spambots. You need JavaScript enabled to view it..

Verified August 2017

 

Resistant Starch Blend Gastrointestinal Impact

Purpose of study: This study aims to test the hypothesis that a unique blend of resistant starches and fiber will promote gastrointestinal health, as measured by an increase in short-chain fatty acids and improvement in quality of life measures in conjunction with microbial community changes. This study specifically evaluates the impact on short-chain fatty acids and gut microbiota and the impact on quality of life from a resistant starch blend in healthy adult humans with occasional gastrointestinal distress.

Sponsor: Metagenics, Inc.

Participation:

• Generally healthy without use of interfering supplements or medications with occasional gastrointestinal symptoms like bloating or irregularity
• Age 21-65 years
• Willingness to maintain current lifestyle (diet and exercise) practices (other than avoiding or limiting alcohol)
• Willing to avoid alcohol during the study OR limit alcohol consumption to 1-2 glasses of light beer or wine for the 1-2 days after the stool collection for visits 2, 3 and 4
• Willingness to give written informed consent to participate in the study.
• Presence of minor symptoms of bloating or constipation or irregular bowel movements
• Willingness and ability to collect per the two stool test kit procedures 10 stool samples at home and ship per instructions
• Willing to have blood drawn 3 times (does not apply to those impacted by circumstances associated with COVID-19 pandemic)
• Ability to speak, read and understand English
• Ability to participate via telemedicine (phone or video calls for study visits and submit documents electronically and receive products and return unused products)

Treatment or Intervention: Dietary Supplement: Resistant Starch Blend or placebo starch

Contact: For more information please contact Kim Koch This email address is being protected from spambots. You need JavaScript enabled to view it. or visit https://clinicaltrials.gov/

Added April 2020 

 

HealthMode / Remote Study of an Electronic Means to Characterize Bowel Movements in Adult Populations

Purpose of study: To find out if a mobile phone application (HealthMode Stool) can serve as a useful tool to track and characterize daily bowel movements.

Sponsor: HealthMode

Participation:

Females and males over 18 years old
Willing to use their own/personal mobile phone (iPhone 6 or higher, running iOS 11 or higher) for participation
Willing to share demographic data with the sponsor of the study
Willing to follow app use instructions during the course of the study
Willing to log the bowel movement events on a daily basis with manual input of additional characteristics
Willing to complete survey instruments as described in study procedures
Willing to provide electronic informed consent
Able to read and understand the english language well enough to complete electronic informed consent

Contact: J. Jamison, L. Kvapilova This email address is being protected from spambots. You need JavaScript enabled to view it.

Added October 2019

 

Participates Needed in the PRISM-CC Study

Purpose of study: Your responses will help the International Chronic and Complex Conditions Research Group (IC3RG) to design a questionnaire to assess patients' ability to self-manage their chronic conditions. After completing the survey, you can enter to win one of four $100 Amazon gift cards. Your contact details will not be linked to your survey responses. You have until December 31st, 2020 to participate in this study.

Sponsor: International Chronic and Complex Conditions Research Group (IC3RG)

Participation: Are you 18 years of age or older, English-speaking, and living with one or more chronic conditions (mental and/or physical)?

Complete a short anonymous and confidential online survey to share your experience with the Patient Reported Inventory of Self-Management of Chronic Conditions (PRISM-CC) Study.

About: This study is approved by the Nova Scotia Health Authority Research Ethics Board (#1025263).

Learn More: https://www.dal.ca/sites/ic3rg/projects/prism.html

Take the Survey (English Only, Works Best on Computer/Laptop): https://surveys.dal.ca/opinio/s?s=55372

Added May 2020

 

Research Study that Gathers Information About the Efficacy, Tolerability, and Accessibility of Different Tube Feeding Formulas in Patients Requiring Jejunal Tube Feedings

Purpose of study: You are invited to participate in a research study that gathers information about the efficacy, tolerability, and accessibility of different tube feeding formulas in patients requiring jejunal tube feedings. This research is to better understand the efficacy, tolerability and implementation of different tube feeding formulas. This information could help to minimize the need to trial multiple different formulas that would delay adequate nutrition. We hope to better understand the real-life patient experience on the tolerability and implementation of tube feeds in patients with various GI disorders requiring jejunal tube feedings.

In this study, you will be asked to complete an online electronic survey to assess your experience with different formulas used for your enteral nutrition. These surveys will be anonymous, voluntary, and responses will be collected in a de-identified manner. There will be no collection of patient names, email addresses, IP addresses or any other personal identifiers that could link responses back to a particular patient. Reminder e-mails will be sent out at 2-3-week intervals. We will allow 2 months in total for responses.

Sponsor: Stanford University 

Participation: Your participation in this experiment to complete the online electronic survey will take on average of 5-10 minutes, maximum of 30 minutes.

Contact: If you have any questions, concerns or complaints about this research study, its procedures, risks and benefits, contact the Protocol Director, Linda Nguyen, MD at (650) 723-5135. Visit here to sign up: https://redcap.stanford.edu/surveys/?s=PRWF8CTMNK

Added June 2020

ClinTrial NIH Healthy

Purpose of study: Doctors at the National Institutes of Health (NIH) seek healthy male volunteers, 18-35 years old with body mass index (BMI) of 18.5-25 kg/m2 to participate in the study. To calculate BMI visit: https://go.usa.gov/xUmyU. This study will collect data about the effects of currently approved anti-obesity drugs on your metabolic rate. Compensation provided to potential participants.

Sponsor: NIH

Participation:

• Have a screening visit including medical history, physical exam, blood tests, and EKG
• Have six visits: (5) one-day overnight inpatient stays and (1) two–night overnight inpatient stay, over a six to twelve week period at the NIH Clinical Center.
• Stay in a temperature-controlled room and wear non-invasive devices to measure activity, heart rate, and temperature
• Receive daily study medications
You may not be eligible if you:
• Have high blood pressure or taking medications to control your blood pressure
• Have diabetes, liver disease, a thyroid condition, or heart disease
• Smoke or use tobacco products

For more information: 

For more information:
NIH Clinical Center Office of Patient Recruitment
866-444-1132
800-877-8339 TTY / ASCII
Se habla español
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Online: https://go.usa.gov/xUmVp
NIH Study: 13-DK-0200

Added April 2020

Top of Page

 Barrett's Esophagus

 ClinTrial Barretts

Purpose of study: The goal of this research is to determine the natural history of Barrett's esophagus (BE) using tethered capsule endomicroscopy (TCE) in patients undergoing surveillance endoscopy.

Sponsor: Massachusetts General Hospital,  National Institutes of Health (NIH) and National Cancer Institute (NCI)

Participation:

Patients with known BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy,
Patients over the age of 18
Patients who are capable of giving informed consent
Patients who had or will have a standard of care EGD within 9 to 15 months
Subjects must have no solid food for at least 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.

Contact: For more information, please visit: clinicaltrials.gov/

Contact: Anna Gao, RN 617-643-6092 This email address is being protected from spambots. You need JavaScript enabled to view it.
Contact: Anita Chung, RN 617-724-4515 This email address is being protected from spambots. You need JavaScript enabled to view it.

Added February 2020

Top of Page

Gastroesophageal Reflux Disease (GERD)

 

ClinTrial 2

Purpose of study: The purpose of this study is to evaluate the safety and efficacy of IW-3718 administered to patients who continue to have persistent symptoms of gastroesophageal reflux disease (GERD), such as heartburn and regurgitation, while receiving once-daily (QD), standard-dose proton pump inhibitors (PPIs).

Sponsor: Ironwood Pharmaceuticals, Inc.

Participation: Adult patients ages 18 and older with a diagnosis of GERD and reporting persistent GERD symptoms (heartburn or regurgitation) while taking standard PPI therapy. Eligible volunteers will be given three tablets twice daily, immediately after the morning and evening meals.

82 US study locations are enrolling for this study.

Contact: For more information, visit the study listing on clinicaltrials.gov.

Added December 2018

Minimally Invasive Surgery of the Gastro-esophageal Junction (MISGEJ)

Purpose of study: This study will assess short and long term outcomes of individuals undergoing minimally invasive surgery of the gastro-esophageal junction (MISGEJ). Patients will respond to questionnaires on an annual basis evaluating quality of life and functionality following MISGEJ. Hospital charts will also be reviewed on an annual basis to assess patient health outcomes.

Sponsor: Ottawa Hospital Research Institute

Participation: All patients undergoing minimally invasive surgery of the gastro-esophageal junction at the Ottawa Hospital.

Contact: Andrew JE Seely, MD, PhDOttawa Hospital Research Institute https://clinicaltrials.gov/

Added September 2020

 

Gastroparesis

ClinTrial 1 17

Purpose of study: Primary Objective: To assess the efficacy of treatment with various dose levels of TAK-906 in adult subjects with gastroparesis compared with placebo during 12 weeks of treatment. Secondary Objectives: To evaluate the safety and tolerability of TAK-906 doses compared with placebo during 12 weeks of treatment.

Additional Objectives: • To evaluate the pharmacokinetics of TAK-906 in subjects with gastroparesis • To evaluate the effect of TAK-906 on quality of life compared with placebo. • To evaluate the potential relationship between changes in C-reactive protein (CRP), glucose-dependent insulinotropic peptide (GIP), peptide tyrosine tyrosine (PYY), clinical symptoms and motility response • To evaluate the effect of TAK-906 on GEBT.

Sponsors: Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited

Participation: Main Criteria for Inclusion:  Subject eligibility is determined according to the following criteria before entry into the study: • Adult men and women aged 18 to 85 years, inclusive, and with body mass index ≥19 to ≤40 kg/m2 inclusive. • Subjects should have symptoms of gastroparesis (eg, postprandial fullness, nausea, vomiting, upper abdominal pain, and early satiety) for at least 3 months before Screening as assessed by a physician.  • Subjects must have an average composite ANMS GCSI-DD symptom score ≥2 during the 7 days before randomization. The predominant symptom experienced by subjects must not be abdominal pain. • Subjects must experience nausea: nausea subscale (of ANMS GCSI-DD) symptom score ≥2 at least 4 of 7 days or an average nausea subscale symptom score ≥2 during the 7 days before randomization. Nausea symptoms must not be attributable to a central disorder (eg, motion sickness, glaucoma, menstrual cycles, migraine headache). • Subjects must have confirmed delayed gastric emptying at Screening: delayed gastric emptying by GEBT, defined as time to gastric half emptying (t1/2) ≥79 minutes (80th percentile). • Absence of gastric outlet obstruction confirmed by upper GI, CT, or endoscopy. Special Inclusion for Subjects with Diabetes Mellitus • Subjects must have glycosylated hemoglobin (HbA1c) ≤11% before the Randomization Visit. 

Contacts: Takeda Study Registration Call Center+1-877-825-3327 This email address is being protected from spambots. You need JavaScript enabled to view it.

Added January 2019

ClinTrial Mass GP

Purpose of study: This is a single-center, randomized pilot study to be conducted at Massachusetts General Hospital. The purpose of this study is to examine the non-pharmacological impact of Cognitive Behavioral Therapy (CBT) on gastroparesis symptoms and other clinical co-comorbidities such as pain, depression, anxiety, and catastrophizing. A subset of the CBT trial patients will undergo careful phenotyping pre- and post- intervention with brain MRI, autonomic function test (AFT), gastric emptying scintigraphy (GES), wireless motility capsule test (WMC), and nutrient drink test (NDT) to determine the impact of CBT on these metrics in patients with gastroparesis. Patients randomly assigned to a standard medical treatment (SMT) group will be treated by the standard of care. Characterization of these relationships or lack thereof can help guide future development of more targeted approaches and optimize treatment strategies for gastroparesis.

Sponsors: Massachusetts General Hospital

Participation:

Male and female patients aged 18 - 65 years old (inclusive)
Symptoms of gastroparesis of at least 12 weeks duration (do not have to be continuous) with varying degrees of nausea, vomiting, early satiety, and/or post-prandial fullness
An idiopathic etiology
GES of solids using 4 hours Egg Beaters® protocol within the last 6 months with either:

- Abnormal gastric emptying rate defined as an abnormal 2 hour (>60% retention) and/or 4 hour (>10% retention) result based on a 4 hour scintigraphic low fat Egg Beaters® gastric emptying study.

Body mass index (BMI) ≥ 17.5 kg/m2
Have not previously received CBT for coping with chronic illness
Have access to a computer with internet access
Speak, write, and understand English
On stable doses of any medication for 30 days prior to entering the study (exceptions are psychotropic, opioids, and/or illicit drugs) and agrees not to change medications or dosages during the study period.

Contacts: For mor information, please visit: https://clinicaltrials.gov/ 

Contact: April Mendez 617-726-0196 This email address is being protected from spambots. You need JavaScript enabled to view it.

Added February 2020

ClinTrial Neurogastrx

Purpose of study: The purpose of the study is to evaluate the safety and efficacy of NG101 (metopimazine mesylate) when administered orally across a range of doses to participants aged 18 years or older with diabetic or idiopathic gastroparesis. Results of the study will guide optimal dose selection for phase 3.

Sponsors: Neurogastrx, Inc.

Participation

  • Adult patients with diabetic or idiopathic gastroparesis
  • Symptoms consistent with gastroparesis (nausea, vomiting, early satiety, post-prandial fullness, and abdominal pain)
  • Documented evidence of no mechanical obstruction
  • Delayed gastric emptying as demonstrated by gastric scintigraphy or breath test

Contacts: Stephen Wax, MD This email address is being protected from spambots. You need JavaScript enabled to view it.

Added April 2020

ClinTrial 1 20

Purpose of study: To study an investigational drug to help symptoms for Diabetic Gastroparesis. 

Sponsors: UNC Center for Esophageal Diseases and Swallowing.

Participation: Do you have Diabetic Gastroparesis? (i.e. : nausea, abdominal pain, post-prandial fullness, bloating, vomiting, and early satiety) If you are at least 18 years of age and currently suffering from symptoms of Diabetic Gastroparesis, you may be eligible for a research study involving an investigational drug to help reduce these symptoms. Study participation could last as long as 12-weeks. Compensation may be included for eligible participants.

Contacts: If you are interested in learning more about this study, please call (919) 843-0821 or email This email address is being protected from spambots. You need JavaScript enabled to view it.

Added January 2019

ClinTrial Vanda

Purpose of study: To evaluate the efficacy of tradipitant relative to placebo in change from baseline to in nausea severity and other symptoms of gastroparesis.

Sponsors: Vanda Pharmaceuticals

Participation: Diagnosed with idiopathic or diabetic gastroparesis with moderate to severe nausea and delayed gastric emptying.

Contacts: Jesse Carlin This email address is being protected from spambots. You need JavaScript enabled to view it.. For more information, please visit gpvandastudy.com 

Added July 2019

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Dose Response of Oral CIN-102 in Adults with Idiopathic and Diabetic Gastroparesis

Purpose: To evaluate the safety and tolerability of multiple doses of a study medication (CIN-102) in subjects with idiopathic or diabetic gastroparesis.

Sponsors: CinDome Pharma Inc., A subsidiary of CinRx Pharma, LLC

Study Population: Key Inclusion/Eligibility Criteria:

• Male and female patients ages 18 to 70 years old.

• Has a current diagnosis of idiopathic or diabetic gastroparesis defined by the following: Has gastrointestinal symptoms felt to be consistent with gastroparesis within 6 months prior to screening, or, has documented delayed gastric emptying within the past 3 years determined by gastroesophageal breath test or scintigraphy.

• Body mass index between 18 and 40 kg/m2, inclusive.

• Glycosylated hemoglobin level <11% at Screening. Other criteria apply.

Contact information: Brendan Doran This email address is being protected from spambots. You need JavaScript enabled to view it. For more information, visit https://clinicaltrials.gov/

Added January 2020

ClinTrial Mayo DB

Purpose: Researchers are trying to determine if subjects with diabetic gastroparesis and symptoms of bloating will have a greater improvement in bloating symptoms when treated with rifaximin.

Sponsors: Mayo Clinic

Study Population: Men and women adult patients, aged 18-75, with diabetic gastroparesis

Diagnosis of diabetic gastroparesis will have been made previously using a combination of symptoms (e.g., nausea, vomiting, bloating, early satiety, abdominal pain), the absence of mechanical obstruction, and delayed gastric emptying using a 4-hour, solid phase scintigraphic study (GES; > 20% remaining at 4 hours)

Contact information: For more information, please visit https://clinicaltrials.gov/ 

Contact: Brian Lacy, MD 904-953-2000 This email address is being protected from spambots. You need JavaScript enabled to view it.
Contact: Cangemi David, MD 904-953-2000 This email address is being protected from spambots. You need JavaScript enabled to view it.

Added February 2020

ClinTrial GP and FD

Purpose: Researchers are looking at the effects of a cannabidiol medication on stomach function in people with gastroparesis (a paralyzed stomach) and people with dyspepsia (an upset stomach caused by improper functioning of the stomach's muscles or nerves).

Sponsors: Mayo Clinic

Study Population: 

  • Patients with gastroparesis or functional dyspepsia
  • Age 18-70 years
  • Patients will be identified from among Mayo Clinic patients.
  • Patients will have symptoms consistent with gastroparesis based on a national guideline (2) for gastroparesis (symptoms PLUS delayed gastric emptying of solids). Patients with Rome IV criteria for postprandial distress syndrome (a subset of functional dyspepsia) (35) will be selected based on gastric emptying of solids which is NOT delayed, in addition to standard FD criteria:
  • Symptoms fulfilled for the last 3 months with onset greater than 6 months before diagnosis:
  • One or more symptoms being bothersome: postprandial fullness, early satiation, epigastric pain or burning
  • Must include one or both of the following at least 3 days per week: bothersome postprandial fullness (i.e., severe enough to impact on usual activities) or bothersome early satiation (i.e., severe enough to prevent finishing a regular-size meal)
  • No evidence of organic, systemic, or metabolic disease to explain the symptoms on routine investigations.
  • Participants will have previously undergone test of gastric emptying of solids using the standardized Mayo Clinic scintigraphic method
  • Ability to provide informed consent
  • Absence of other diseases (structural or metabolic) which could interfere with interpretation of the study results
  • Body mass index of 18-35 kg/m2

Contact information: For more information, please visit https://clinicaltrials.gov/  

Contact: Kayla Arndt (507) 538-6599 This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact: Sara Linker Nord(507) 266-1999

Added February 2020

ClinTrial Gp R

Purpose: To create a new registry of patients with symptoms of gastroparesis, both those with delayed gastric emptying and patients with similar gastroparesis symptoms but normal gastric emptying, for the enhanced study of symptoms, gastric motility abnormalities, patient characteristics, and degree of morbidity; To follow a well-characterized cohort to further define the natural history and clinical course of patients with symptoms of gastroparesis – both symptoms and gastric emptying over time; To provide a reliable source for recruitment of well-characterized patients with gastroparesis for other studies including therapeutic clinical trials, pathophysiological, molecular, histopathologic, or other ancillary studies.

Sponsors: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Population: 1.) Symptoms of gastroparesis of at least 12 weeks' duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness; 2.) An etiology of either diabetic, idiopathic, or post-fundoplication (Nissen, Dor, or Toupet) gastroparesis or gastroparesis-like disorder (symptoms of gastroparesis but normal gastric emptying); 3.) Gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 6 months with either: a.) Abnormal gastric emptying rate defined as an abnormal 2 hour (>60% retention) and/or 4 hour (>10% retention) result based on a 4 hour scintigraphic gastric emptying study. (This group will comprise ~75% of patients in the registry.) or b.) Patients with a normal gastric emptying rate, but who have symptoms of gastroparesis. (This group will comprise ~25% of patients in the registry.); 3.) Negative upper endoscopy or upper radiographic GI series within 2 years of registration; 4.) Age at least 18 years at initial screening visit

Contact information: Laura Miriel This email address is being protected from spambots. You need JavaScript enabled to view it., or for more information visit here

Verified September 2020

ClinTrial GP Peds

 

Purpose: To create a national prospective registry of children and adolescents with gastroparesis and gastroparesis-like syndrome (symptoms of gastroparesis but normal gastric emptying) to include demographic, clinical, psychological, nutritional characteristics, physiological measures, and serial assessments of symptoms over 3 years during their clinical care; to establish a biorepository of plasma, serum, peripheral blood mononuclear cells (PBMC), GI mucosal biopsies (in those undergoing upper GI endoscopy), urine and stool collected from the children and adolescents in this registry which will allow for future analyses such as cytokines, bacterial DNA and microbiome to investigate the etiology and pathogenesis of gastroparesis in children.

Sponsors: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Population: 1.) Cardinal symptoms of gastroparesis of at least 12 weeks duration. Cardinal symptoms of gastroparesis are the constellation of some combination of: nausea, vomiting, early satiety, postprandial fullness; symptoms sometimes may be accompanied by upper abdominal pain; 2.) An etiology of either diabetic, idiopathic, or post-fundoplication gastroparesis or gastroparesis-like disorder (symptoms of gastroparesis but normal gastric emptying; see below); 3.) Gastric emptying scintigraphy (GES) of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 6 months with either: a.) Abnormal gastric emptying rate defined as an abnormal 2-hour (>60% retention) and/or 4-hour (>10% retention) result based on a 4-hour scintigraphic gastric emptying study. (This group will comprise ~75% of patients in the registry) or b.) Patients with a normal gastric emptying rate, but who have symptoms of gastroparesis. (This group will comprise ~25% of patients in the registry); 4.) Age at least 5 years, and under 18 years at initial screening visit

Contact information: Laura Miriel This email address is being protected from spambots. You need JavaScript enabled to view it., or for more information visit here

Verified September 2020

ClinTrial BESST

Purpose: This trial evaluates whether the study medication, buspirone (a 5-hydroxytryptamine (5-H T) 1a receptor agonist), improves the symptoms of gastroparesis in patients with gastroparesis symptoms and at least moderately severe symptoms of fullness and/or inability to eat a full meal. After enrollment, participants aged 18-75 years will be treated with buspirone (10 mg three times per day) or a matching placebo for 4 weeks, followed by a 2-week post-treatment washout period. The primary outcome for the study is 4-week change (week 4 minus baseline) in the 4-item postprandial fullness/early satiety subscore (higher scores indicate worse symptoms) from the Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) Gastroparesis Cardinal Symptom Index (GCSI).

Sponsors: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Population: 1.) Age 18 to 75 years of age at initial screening interview; 2.) Symptoms compatible with gastroparesis or other functional gastric disorder for at least 3 months (does not have to be contiguous) prior to initial screening interview; 3.) Diagnosis of either diabetic or idiopathic gastroparesis; 4.) Delayed or normal gastric emptying retention on screening 4-hour Gastric Emptying Scintigraphy test; 5.) Symptoms of gastroparesis measured by the 9-item PAGI-SYM Gastroparesis Cardinal Symptom Index (GCSI) total score > 2.0 at enrollment; 6.) Symptomatic with postprandial fullness/early satiety severity at enrollment using the PAGI-SYM GCSI post-prandial fullness/early satiety subscore ≥ 3; 7.) Upper endoscopy or upper GI series without ulcers or mass lesions in the 2 years prior to enrollment

Contact information: Laura Miriel This email address is being protected from spambots. You need JavaScript enabled to view it., or for more information visist here

Verified September 2020

Top of Page

 

Rare Genetic Diseases

Recruiting Individuals with Rare Genetic Disorders

Purpose of study: In an effort to help researchers working to understand gastrointestinal motility diseases like mitochondrial nueorgastrointestinal encephalopathy, blood samples and clinical data from individuals with rare genetic diseases are being collected. The samples are made anonymous and shared with scientists to use in their research for treatments and causes. Families living outside the US are also welcome to donate a sample to the repository.

Sponsors: The National Institute of General Medical Sciences (NIGMS) Human Genetic Cell Repository Program and Coriell Institute for Medical Research

Participation: Eligible individuals with an inherited genetic disease or chromosomal abnormality

Contacts: Families who want to participate in this research effort can can read more about the Repository and donation process here, or can contact the NIGMS Human Genetic Cell Repository genetic counselor, Tara Schmidlen, MS, CGC, for postage-paid sample collection kits and the necessary paperwork: Phone: 856-757-4822, Email: This email address is being protected from spambots. You need JavaScript enabled to view it..

Verified August 2017

Top of Page

 

Pediatric Gastrointestinal Disorders

 

ClinTrial 1 22

Purpose of study: The purpose of this research study is to learn more about the relationship between children's bowel habits and the way they react to sensory input. Some children are very sensitive to the way things feel, smell, and sound, and this might interfere with their willingness to use the toilet for a bowel movement. Eligible participants will be asked to complete 4 questionnaires with questions related to these reactions to sensation and bowel habits of children.

Sponsor: University of Newcastle

Participation: Parents of children between ages 3 and 6 years. The study will include children with or without functional defecation issues who may or may not also have a diagnosis of ADHD or autism. Excluded from the study are children with organic defecation issues and/or a diagnosis other than ADHA or autism. 

Contact: Enter your information on this online contact form to receive additional study information or contact Isabelle Beaudry-Bellefeuille at This email address is being protected from spambots. You need JavaScript enabled to view it.

Added August 2017

Celiac Disease

Participants Needed for POWER-C Study

Purpose of study: The POWER-C (Promotion of Optimal Well-Being, Education, and Regulation for Celiac Disease) study is a free online, evidence-based program for people newly diagnosed and/or struggling with celiac disease. The purpose of the study is to examine the impact of an 8-week online program containing 4 modules to be completed bi-weekly in adults with celiac disease. Participants will be asked to complete online questionnaires at 4 time points.

Sponsor: University of Calgary

Participation: Adult individuals (ages 18+) located in North America diagnosed with celiac disease (blood test and/or biopsy). Eligible individuals are required to follow a strict gluten-free diet to participate.

Contact: Dr. Justine Dowd. Phone: 1-403-210-8482. Email: This email address is being protected from spambots. You need JavaScript enabled to view it.. For additional information: www.cureceliacdisease.org/wp-content/uploads/power_c.pdf.

Verified May 2018

Chronic Intestinal Pseudo-Obstruction

Diagnostic Gene Studies for Chronic Intestinal Pseudo-Obstruction

A mutation in a gene transmitted through a dominant mode of inheritance (an affected person having a 50% risk of passing the disorder to each of his or her children) can cause chronic intestinal pseudo-obstruction (CIPO), with or without frequent bladder involvement. The disorder can also occur due to a new mutation. Thus far, the most important gene discovered with mutations is the ACTG2 gene.

A second gene is being sought by the Center for Human Genetics. Families who wish to participate in this research effort can email Aubrey Milunsky, MD at This email address is being protected from spambots. You need JavaScript enabled to view it. for details.

Verified May 2018

Irritable Bowel Syndrome (IBS)

 

ClinTrial 1 24

Purpose of study: This study involves free nutrition sessions with a skilled IBS-specializing dietitian.

Sponsor: UCLA Oppenheimer Family Center for Neurobiology of Stress

Participation: Eligible male and female individuals ages 18 and older with a diagnosis of IBS with diarrhea or diarrhea with constipation (IBS-D or IBS-M). To participate, individuals must not have tried the low FODMAP diet before.

Contact: For more information, visit www.uclacns.org/patients/clinical-research or call (310) 206-1656. You may also email Nafessa Islam at This email address is being protected from spambots. You need JavaScript enabled to view it..

Verified May 2018

ClinTrial IBS and Diet

Purpose of study: The purpose of this study is to study the relationship between the bile acids, short chain fatty acids and bacteria within the intestines. The hypothesis is that changes in the bacterial composition of the stool are associated with the differences in bile acids and short chain fatty acids in patients having irritable bowel syndrome compared to healthy individuals.

Sponsor: Indiana University and NIDDK

Participation: Patients with IBS, ages 18-65 fulfilling Rome IV criteria and asymptomatic controls with no prior history of GI disease or symptoms.

Participants should be on a stable and consistent diet regimen and should not be following an extreme diet intervention such as gluten-free or a low FODMAP diet at the time of study participation.

Contact: For more information, visit clinicaltrials.gov/ 

Contact: Tonya Hamilton 317-278-9296 This email address is being protected from spambots. You need JavaScript enabled to view it.
Contact: Anita Gupta 317-948-9227 ext 3179489227 This email address is being protected from spambots. You need JavaScript enabled to view it.

Added February 2020

Copy of ClinTrial Mexico

Purpose of study: The combination of Lactobacillus fermentum and Lactobacillus delbrueckii (Lactobacillus LB) has proven to be effective and safe for treatment of acute diarrhea in children. Also, a clinical trial in adult patients with chronic diarrhea, showed a reduction in the number of daily stools. However, the evidence is not enough regarding the efficacy and safety of Lactobacillus LB for treatment of patients with irritable bowel syndrome with predominance of diarrhea (IBS-D).

Sponsor: Hospital General de Mexico

Participation: Patients meeting Rome IV criteria for IBS-D, without specific medical treatment for the last 4 weeks prior to inclusion in this study.

Contact: For more information, visit https://clinicaltrials.gov/ or email This email address is being protected from spambots. You need JavaScript enabled to view it.

Added February 2020

Arena ClinTrial

Purpose of study: The CAPTIVATE study will evaluate how an investigational study medication called olorinab works in people with IBS who are experiencing abdominal pain.

Sponsor: Arena Pharmaceuticals, Inc.

Participation: Inclusion criteria include patients who are 18–70 years of age, have been diagnosed with IBS-C or IBS-D, and who experience abdominal pain due to IBS. Other eligibility criteria apply. Patients should visit MyIBSPainStudy.com or talk to their doctor to discuss if the CAPTIVATE trial may be right for them.

After completing the main study, participants may also be eligible to participate in an optional long-term extension (LTE) study for up to an additional 13 months where all participants will receive olorinab.

Contact: For more information, email This email address is being protected from spambots. You need JavaScript enabled to view it.

Updated April 2020

ClinTrial 1 25

Purpose of study: The purpose of this study is to examine brain networks at rest in chronic pain conditions compared to healthy controls.

Sponsor: UCLA Oppenheimer Family Center for Neurobiology of Stress

Participation: Men and women between the ages of 18 and 55 who are diagnosed with IBS, right handed, not pregnant and no significant neurological or psychological medical history.

About the study: Participation involves a screening visit, an MRI and one stool sample.

Participants will be compensated up to $100 and get a digital picture of your brain.

Contact: For more information, visit www.uclacns.org/patients/clinical-research or call (310) 206-8545. You can also email Nafeesa Islam at This email address is being protected from spambots. You need JavaScript enabled to view it..

Added May 2018

ClinTrial Tai Chi

Purpose of study: The purpose of the study is to evaluate the efficacy of Tai Chi practice in reducing symptoms of Irritable Bowel Syndrome with Constipation (IBS-C).

Sponsor: Massachusetts General Hospital

Participation:

  • Age 18 - 65 years
  • BMI ≤ 35
  • Rome IV criteria for IBS-C
  • Continued IBS-C throughout run-in period
  • Compliant with reporting during run-in
  • Ability to follow verbal and written instructions
  • Ability to record daily patient reported outcomes via RedCap survey
  • Ability to use the GeoPain app on a smart phone
  • Informed consent form signed by the subjects

About the study:

This is a single-center pilot study investigating the efficacy of Tai Chi practice in reducing symptoms of IBS. The investigators hope that subjects practicing Tai Chi will have reduced symptoms of IBS-C as measured through overall global symptom relief as well as the IBS-SSS, IBS-QOL, VSI, HADS, Visual Analogue Pain Scale, and changes in bloating, abdominal pain, abdominal distention, and constipation severity. The study will also use daily entries made through the GeoPain app to record trends in pain intensity.

Contact: For more information, please visit: https://clinicaltrials.gov/ 

Contact: Mimi Paz, BA 617-643-5742 This email address is being protected from spambots. You need JavaScript enabled to view it.
Contact: Kyle Staller, MD, MPH 617-724-6038 This email address is being protected from spambots. You need JavaScript enabled to view it.

Updated September 2020

ClinTrial 1 26

Purpose of study: To provide treatment to patients with IBS-D.

Sponsor: University of Michigan and Michigan Institute for Clinical and Health Research (MICHR)

Participation: Men and women over the age of 18 diagnosed with IBS-D. Prior colonoscopy or sigmoidoscopy within the past 2 years with random colon biopsies to exclude the presence of microscopic colitis.

About the study: Patients will receive either rifaximin or low FODMAP dietary intervention.

Contact: For more information, visit https://clinicaltrials.gov/ct2/ or contact Dr. Allen Lee at (734) 936-9454, This email address is being protected from spambots. You need JavaScript enabled to view it..

Added May 2018

 

Participants Sought for Study on Complementary Approaches to the Treatment of IBS

Purpose of study: The purpose of this study is to find a complementary treatment to help Irritable Bowel Syndrome (IBS) patients in need of relief.

About The Study: The length of this study will be three weeks long, with a short online intervention everyday to help individuals deal with their body’s reactions to their environments. Participants will have additional surveys to assess their overall state at the beginning of the study, at the end of the three week intervention, and again at six weeks for a follow-up.

Participation: Eligible individuals between the ages of 18 – 65 years of age who are experiencing pain or discomfort associated with their gut. Cannot be smokers or have an inflammatory bowel disease.

How to Sign Up: http://bit.ly/IBS_study

There will be a $15 Target gift card for first 30 participants upon completion of study.

Study Contact: Jenna N. Ray,  Health Psychologist. Phone: (919) 257 – 7291, Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Verified August 2017

 

Canadian IBS and IBD Patients Needed for IMAGINE (Inflammation, Microbiome, and Alimentation: Gastro-Intestinal and Neuropsychiatric Effects) Study

Purpose of study: The overall aim of IMAGINE Network is to understand the interactions between diet-microbiome-host and find new therapies for the treatment of IBS, IBD and associated psychiatric disorders.

Develop innovative therapies (changes in diet, probiotics, fecal transplants or antibiotics) to improve IBD, IBS and mental health
Improve outcomes of existing therapies through the assessment of diet-microbiome-host interactions
Develop strategies to optimize current therapies to target those who will most benefit from medication as well as identify those in whom medication can be safely discontinued with significant personal benefit and cost savings to the Canadian healthcare system

About The Study: Transform the management of IBD and IBS and associated mental health issues with these disorders.

Sponsor: The IMAGINE (Inflammation, Microbiome, and Alimentation: Gastro-Intestinal and Neuropsychiatric Effects) Chronic Disease Network involves 17 hospitals/universities and 75 researchers across Canada who will study the interactions between the inflammation, microbiome, diet and mental health in patients with inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS).  The IMAGINE Network is one of five chronic disease networks in the SPOR (Strategy for Patient Oriented Research) initiative of CIHR (Canadian Institutes of Health Research).

Participation: Persons from across Canada are being invited to participate in the IMAGINE Network. You may be eligible to participate in this study if you have been diagnosed by your physician with Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), including ulcerative colitis or Crohn’s disease or are a healthy individual without gastrointestinal symptoms.

You will not be eligible to participate if you have any of the following criteria:

Age under 4 years.
Past gastrointestinal bypass surgery or major bowel resections unrelated to Crohn’s disease.
Major concurrent illness such as chronic kidney disease, chronic liver disease other than primary sclerosing cholangitis, chronic immune disease unrelated to IBD.
If you have an active eating disorder such anorexia nervosa or bulimia.
If you cannot communicate in either French or English.

Due to the specific nature of this research, we require that participants have not had major gastrointestinal surgery (e.g. Roux en y, bowel resection), do not have additional disease(s) that might affect ability to participate (e.g. decompensated liver disease), prescription or non-prescription drug use that is known to cause gastrointestinal (GI) symptoms (e.g. chronic antibiotic use), fad diets or eating disorders that may cause GI symptoms.

Study Contact: Aida Fernandes, Executive Director This email address is being protected from spambots. You need JavaScript enabled to view it. or visit http://imaginespor.com/participate-in-research/

Added May 2020

 

 

Accidental Bowel Leakage (or Incontinence)

ClinTrial 1 42

Purpose of study: This 12 week Phase III study will assess the efficacy and safety of a combination clonidine and colesevelam compared with placebo in women with diarrhea and urge predominant fecal incontinence.

Sponsor: NIH and Mayo Clinic

Participation: Women aged 18 to 80 years of age with diarrhea and urge predominant or combination (urge and passive) fecal incontinence for at least one year duration.

ContactKelly Feuerhak (email: This email address is being protected from spambots. You need JavaScript enabled to view it. or phone: 507-255-6802), Subhankar Chakraborty (email: This email address is being protected from spambots. You need JavaScript enabled to view it. or phone: 507-255-4803), or Adil Bharucha (email: This email address is being protected from spambots. You need JavaScript enabled to view it. or phone: 507-284-2687). Refer to this study by its ClinicalTrials.gov identifier NCT02628262

Verified August 2017

ClinTrial 43

Purpose of study: The purpose of this study is to compare 3 treatments for fecal incontinence (FI), Biofeedback (BIO), Sacral Neural Stimulation (SNS), and Injections of bulking agents (INJ) in the anal canal and rectum.

Sponsor: The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of North Carolina, Chapel Hill, Mayo Clinic, Colon and Rectal Surgery Associates, Ltd., Augusta University andRTI International

Participation: Physician diagnosis of FI (R15) for the past 6 months or longer, average >2 solid, liquid, or staining FI episodes per week by self-report and during the two-week baseline, meets criteria for SNS and dextranomer treatment except an internal anal sphincter defect of 120 degrees or less, able to ambulate independently on level surfaces, and less than 75% reduction in the number of FI episodes after 4 weeks of EMM.

Contact: For more information on this study, visit www.med.unc.edu/research/.

added April 2019

ClinTrial 44

Purpose of study: The purpose of this study is to investigate the short term (8 weeks) and long term (1 year) efficacy and safety of translumbosacral neuromodulation therapy for fecal incontinence. Treatment is anorectal manometry, translumbosacral anorectal magnetic stimulation, anal ultrasound, and cortical evoked potentials .

Sponsor: National Institutes of Health (NIH) R01

Participation: Recurrent episodes of FI for 6 months; No mucosal disease (colonoscopy + biopsy); On a 2-week stool diary patients reported at least one episode of solid or liquid FI/week.

Contact: Yun Yan (email:This email address is being protected from spambots. You need JavaScript enabled to view it.)

verified September 2020

ClinTrial Restore study

Purpose of study: This trial studies how well sacral nerve stimulation works in treating low anterior resection syndrome or fecal incontinence (the body's passage of stool without control) in patients with rectal cancer that has spread to nearby tissues or lymph nodes, or other pelvic cancer. Sacral nerve stimulation is a permanent implant that may improve bowel functions by stimulating the nerves that control the muscles related to bowel function.

Sponsor: M.D. Anderson Cancer Center in collaboration with National Cancer Institute (NCI)

Participation

Cohort 1: Patients with pathologically proven diagnosis of primary rectal cancer
Cohort 1: Patients who have previously undergone surgical resection and anastomosis (restorative) with curative intent treatment with or without chemoradiation
Cohort 1: Patients with T1 and T2 pathologic stage patients treated with restorative surgical resection without radiation
Cohort 1: Patients with locally advanced rectal adenocarcinoma (T3 and T4 or lymph node positive) treated with radiation and restorative surgery
Cohort 1: Patients with self-reported FI or LARS
Cohort 1: Patients must be able to speak and understand English
Cohort 1: Patients must be willing to and able to sign an approved informed consent document
Cohort 1: Patients must be >= 24 months post-resection of rectal cancer
Cohort 1: Patients must have failed prior conservative measures such as Metamucil and motility medications and already been assessed and treated in a pelvic floor rehabilitation program (biofeedback) designed to treat FI and LARS, and continue to experience significant defecatory dysfunction, allowable per principal investigator (PI) discretion
Cohort 1: Patients must be willing and able to complete Patient Reported Outcomes Questionnaires for before device placement, during the testing phase following lead placement, and after implantation of the battery
Cohort 1: Patients must be willing and able to undergo elective ARM testing to objectively measure pelvic floor function
Cohort 1: Patients who have an average resting tone < 40 mmHg (normal > 40 mmHg) and maximal tolerance < 200 milliliters (normal 200-300 milliliters) as measured by ARM
Cohort 2: Patients with pathologically proven malignancy of the pelvis, other than rectal cancer (e.g. prostate, bladder, anus, vagina, vulva, cervix, uterus, or ovary)
Cohort 2: Patients treated with standard of care radiation therapies without surgical resection
Cohort 2: Patients with self-reported FI or other defecatory dysfunction
Cohort 2: Patients must be able to speak and understand English
Cohort 2: Patients must be willing to and able to sign an approved informed consent document
Cohort 2: Patients must be >= 18 months post-pelvic chemoradiation
Cohort 2: Patients must have already been assessed and treated in a pelvic floor rehabilitation program design to treat FI or other defecatory dysfunction and continue to experience significant defecatory dysfunction
Cohort 2: Patients must be willing and able to complete Patient Reported Outcomes (PROs) and bowel and bladder diaries (Medtronic) at multiple times during the study
Cohort 2: Patients must be willing and able to undergo elective ARM testing to measure pelvic floor function
Cohort 2: Patients who have an average resting tone < 40 mmHg (normal > 40 mmHg) and maximal tolerance < 200 milliliters (normal 200-300 milliliters) as measured by ARM

Contact: Craig A. Messick 713-792-6940 This email address is being protected from spambots. You need JavaScript enabled to view it.. Refer to this study by its ClinicalTrials.gov identifier NCT04066894

added January 2020

Gulf War Multisymptom Illness

ClinTrial 1 39

Purpose of research: The onset of certain gastrointestinal (GI) disorders, including irritable bowel syndrome (IBS), functional dyspepsia, and chronic abdominal pain syndrome, can be triggered by severe stress and infections of the digestive tract. Deployed military personnel face an elevated chance of experiencing these risk factors and developing a disorder as a result of their service. A prominent condition affecting Veterans of the Gulf War theater of operations is a cluster of medically unexplained chronic symptoms. Collectively, these are referred to as "multisymptom illness."

The War Related Illness and Injury Study Center (WRIISC) regularly conducts research into these illnesses to understand the underlying mechanisms and develop treatments to help manage symptoms. 

Sponsor: US Department of Veterans Affairs (VA) 

Participation: Veterans of active service in the Gulf War theater of operations.

Contact: For more information or to participate go to www.warrelatedillness.va.gov. 

Added March 2018

Colorectal Cancer

Check back later for studies.

ClinTrial 45

Sponsor: Vibrant LTD

Participation: Inclusion criteria:  1. Subjects aged 22 years and older. 2. Subjects with Chronic Idiopathic Constipation (CIC) according to Rome III criteria and who have not experienced relief of their symptoms from available therapies (osmotic and stimulant laxatives used for at least one month at recommended dose). 3. Subjects with an average of <3 Spontaneous Bowel Movements (SBM) per week. 4. Normal colonoscopy performed within 5 years prior to study participation, unless the subjects are <50 years old and without alarm signs and/or symptoms. 5. Subject signed the Informed Consent Form (ICF). 6. Female subjects must have a negative blood pregnancy test during screening, confirmed by a negative urine pregnancy test during baseline and must not be lactating prior to receiving study medication.

Contact: Tennekoon Karunaratne (email: This email address is being protected from spambots. You need JavaScript enabled to view it.)

verified September 2020

Short Bowel Syndrome (SBS)

ClinTrial 1 41

Purpose of study: Registry to evaluate the long-term safety profile for patients with SBS who are treated with teduglutide in a routine clinical setting. 

Sponsor: Shire

Participation: SBS patients treated and not treated with teduglutide will be enrolled. All ages accepted. This is an observational study. Data will be collected during routine consultations and clinical staff will enter this information into a system baseline and approximately every 6 months following. Each patient will be followed for at least 10 years.

Contact: Shire contact This email address is being protected from spambots. You need JavaScript enabled to view it.. ClinicalTrials.gov identifier: NCT01990040

Added July 2018

 ClinTrial EOE

Purpose of research: Single center observational and specimen banking study for children with eosinophilic esophagitis EoE to gauge natural history and inflammatory markers.

Sponsor: University of California, San Diego, NIH and NIAID

Participation:

Have a known EoE diagnosis
Complain of dysphagia, vomiting, or abdominal pain, especially if recalcitrant to acid blocking therapy (but does not have to be recalcitrant to acid blocking medications)
Present with food impaction
Present with esophageal stricture
Have characteristic endoscopic findings of EoE of pallor, linear furrows, lichenification, white plaques, or concentric rings

Contact: For more information or to participate go to https://clinicaltrials.gov/

Contact: Emad Khosh hemmat, BS 8589661700 ext 226884 This email address is being protected from spambots. You need JavaScript enabled to view it.
Contact: Seema S Aceves, MD, PhD 8585342983 This email address is being protected from spambots. You need JavaScript enabled to view it.

Added February 2020

 

Outcome Measures for Eosinophilic Gastrointestinal Diseases across Ages

Purpose of study

CEGIR is conducting this study because they want to learn more about Eosinophilic Gastrointestinal Diseases (EGIDs). As part of that goal, one area of study will compare how well a patient feels – their symptoms – with what the tissue samples look like under a microscope. The study aims to answer a series of questions, including the following:

What if the tissue looks good, but you are still experiencing symptoms?
What if the symptoms have subsided, but the eosinophil counts haven’t changed?
This study is designed to give researchers and clinicians a better idea of the correlation of symptoms to the tissue, help them find clues about the disease in the tissue samples, and assess how this information could be used in the future to help guide diagnosis and treatment plans.

OMEGA is a multicenter, longitudinal study of children and adults with EoE, EG, and EC.

Participation: CEGIR is conducting this study because they want to learn more about Eosinophilic Gastrointestinal Diseases (EGIDs). As part of that goal, one area of study will compare how well a patient feels – their symptoms – with what the tissue samples look like under a microscope. The study aims to answer a series of questions, including the following:

What if the tissue looks good, but you are still experiencing symptoms?
What if the symptoms have subsided, but the eosinophil counts haven’t changed?
This study is designed to give researchers and clinicians a better idea of the correlation of symptoms to the tissue, help them find clues about the disease in the tissue samples, and assess how this information could be used in the future to help guide diagnosis and treatment plans.

OMEGA is a multicenter, longitudinal study of children and adults with EoE, EG, and EC.

Contacts: To look up a contact in your state, visit here.

Added September 2020

 ClinTrial PCORI

Purpose of Study: The COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is a pragmatic, patient-level randomized superiority trial of elective colectomy vs. best medical management for patients with quality of life (QoL) limiting diverticular disease. A parallel observational cohort will include those who are disinclined to have their treatment choice randomized, but are willing to contribute information about their outcomes. The goal of the COSMID trial is to answer the question: For patients with QoL-limiting diverticular disease, is elective colectomy more effective than best medical management? The hypothesis being tested in the COSMID trial is that patient-reported outcomes (PROs) among patients in the surgery arm will be superior to those in the best medical management arm.

Sponsor: Patient Centered Outcomes Research Institute

Participation: Adults ≥18 years; At least one episode of diverticulitis confirmed by CT scan in last 5 years and a colonoscopy to rule out or screen for other colon pathology concordant with screening guidelines; AND A. History of recurrent uncomplicated diverticulitis without current symptoms (AUD in remission) over the prior 5 years; OR B. Persistent signs, symptoms, and concerns related to diverticular disease ≥3 months after recovery from an episode of AUD (e.g., excluding irritable bowel syndrome and other conditions in coordination with gastroenterologist)

Contact: Kelsey Pullar This email address is being protected from spambots. You need JavaScript enabled to view it.

Added December 2019

ClinTrial DEBUT

Advancing Nutritional Science for Children With Functional Dyspepsia

Purpose of study: Food can often exacerbate gastrointestinal symptoms in adults and children with functional dyspepsia. However, it is unclear which foods exacerbate symptoms more than others.

Children with post-prandial distress functional dyspepsia will receive four different meals with variables being: semi-solid vs. solid and high fat vs high carbohydrate. At the time of ingestion and for up to 3 hours after each meal, subjects will rate their gastrointestinal symptoms. Comparisons of symptom onset and severity will be made for each meal.

Enrolled subjects will have undergone previous gastrointestinal evaluations: gastric emptying study and/or upper endoscopy. In addition, subjects will complete psychosocial measures: Behavioral Assessment for Children-3, childhood somatization inventory.

The first goal is to compare the severity of gastrointestinal symptoms with different composition and consistency meals. The second goal is to correlate the severity of postprandial gastrointestinal symptoms to psychosocial distress, gastric neuromotor function (emptying and accommodation), and duodenal inflammation.

Sponsor: Baylor College of Medicine

Participation: Rome IV Functional Dyspepsia with post-prandial distress

Previously completed normal upper endoscopy with duodenal biopsies and/or previously completed a gastric emptying scintigraphy study

Ages 10-17

Contacts:

Contact: Deshara Watson 832-826-2271 This email address is being protected from spambots. You need JavaScript enabled to view it.
Contact: Bruno Chumpitazi, MD This email address is being protected from spambots. You need JavaScript enabled to view it.

ClinicalTrials.gov identifier: NCT04053049

Added September 2020

Cyclic Vomiting Syndrome

Auricular Neurostimulation for Cyclic Vomiting Syndrome

Purpose of study: Cyclic vomiting syndrome (CVS) is an difficult to treat and debilitating functional gastrointestinal disorder. Majority of children and adults with CVS have concurrent severe abdominal pain and migraine-features, rendering them incapacitated during the vomiting cycle.

The vagus nerve carries signals of nausea, vomiting and pain between the brain and the gastrointestinal tract and is part of the autonomic nervous system. The autonomic nervous system appears to be in imbalance in patients with CVS during a vomiting cycle. By stimulating a branch of the vagus nerve in the outer ear, this study aims to improve symptoms and quality of life in both children and adults with CVS.

Subjects will be randomized to receive active vs sham (non-active) neurostimulation therapy for 5 days at the onset of a CVS cycle. They will then cross over to the other group (active vs sham) at the onset of the next CVS cycle. Subjects in a separate sub-study receive 6 weeks of active neurostimulation therapy (5 days/week). Pain, nausea, vomiting, anxiety, quality of life, potential side effects and overall symptom improvement will be monitored before and after therapy for the entire study.

Sponsor: Medical College of Wisconsin

Participation: Ages 8-65

Meeting Rome IV Pediatric or Adult criteria for Cyclic Vomiting Syndrome (CVS)
Concurrent abdominal pain with CVS cycle
English-speaking
Lack of other explanation for symptoms
Either predictable, 'calendar-timed' episodes or prodromal symptoms for 12-24 hours that are predictive of episodes onset

Contacts: Contact: Louis Pawela, BS 414-266-6728 This email address is being protected from spambots. You need JavaScript enabled to view it., or visit here for more information.

Added September 2020

What are Phases?

Value of diet app for increasing adherence to Low FODMAP Diet (LFD)

Patients with gastroparesis or functional dyspepsiaAge 18-70 yearsPatients will be identified from among Mayo Clinic patients.Patients will have symptoms consistent with gastroparesis based on a national guideline (2) for gastroparesis (symptoms PLUS delayed gastric emptying of solids). Patients with Rome IV criteria for postprandial distress syndrome (a subset of functional dyspepsia) (35) will be selected based on gastric emptying of solids which is NOT delayed, in addition to standard FD criteria: Symptoms fulfilled for the last 3 months with onset greater than 6 months before diagnosis:One or more symptoms being bothersome: postprandial fullness, early satiation, epigastric pain or burningMust include one or both of the following at least 3 days per week: bothersome postprandial fullness (i.e., severe enough to impact on usual activities) or bothersome early satiation (i.e., severe enough to prevent finishing a regular-size meal)No evidence of organic, systemic, or metabolic disease to explain the symptoms on routine investigations.Participants will have previously undergone test of gastric emptying of solids using the standardized Mayo Clinic scintigraphic methodAbility to provide informed consentAbsence of other diseases (structural or metabolic) which could interfere with interpretation of the study resultsBody mass index of 18-35 kg/m2Several medication classes, particularly those affecting gastrointestinal transit or motor functions, will be excluded, including GLP-1 receptor or amylin agonists in patients with diabetes mellitus. Stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardioprotection, and birth control (but with adequate backup contraception, as drug interactions with birth control have not been conducted for secretin PAM) are

 

Adult patients with diabetic or idiopathic gastroparesis Symptoms consistent with gastroparesis (nausea, vomiting, early satiety, post-prandial fullness, and abdominal pain) Documented evidence of no mechanical obstruction Delayed gastric emptying as demonstrated by gastric scintigraphy or breath test

NCT03587142

Research Awards
2020 Award Recipients
Kyle Staller, MD
Christopher V. Almario, MD
Maria Raffaella Barbaro, PhD
2019 Award Recipients
Arpana Gupta, PhD
David Levinthal, MD, PhD
Ilan Koppen, MD, PhD
2018 Award Recipients
Amaranath Karunanayake, PhD
Katja Kovacic, MD
Cristina Martinez, PhD
Ans Pauwels, PhD
2013 Award Recipients
Enrico Corazziari, MD
Jan Tack, MD, PhD
Report from Gary Mawe, PhD: The Roles of Intestinal Nerves and Serotonin in Gut Function and Dysfunction
Ashley Blackshaw, PhD
Carlo Di Lorenzo, MD
Niranga Manjuri Devanarayana, MD
Report from Lukas Van Oudenhove, PhD: Solving the Biopsychosocial Puzzle in Functional Dyspepsia
Muriel Larauche, PhD
2011 Award Recipients
Report from Ronnie Fass, MD: Sleep and Gastroesophageal Reflux Disease (GERD)
Million Mulugeta, PhD
Adrian Miranda, MD
Samuel Nurko, MD
Sudarshan Jadcherla, MD
Shaman Rajindrajith, MD
2009 Award Recipients
Satish Rao, MD
Emeran Mayer, MD
Javier Santos, MD
Report from Martin Storr, MD, PhD: Functional Gastrointestinal Disorders: New Insights in Enteric Regulation
Report From Miguel Saps, MD: Functional Abdominal Pain in Children and Adolescents
2007 Award Recipients
Report from Bruce D. Naliboff, PhD: Symptom Based Psychology for Functional Gastrointestinal Disorders
Report from Magnus Simrén, MD, PhD: Irritable Bowel Syndrome: Searching for Underlying Causes
Report from Brennan M. R. Spiegel, MD, MSHS: Diagnostic Testing in Irritable Bowel Syndrome: Theory vs. Reality
Report from Sylvie Bradesi, PhD: Role of the Central Immune System in Functional Disorders
Paul E. Hyman, MD
Report from Miranda A. L. van Tilburg, PhD: Home Based Guided Imagery to Treat Pediatric Functional Abdominal Pain
Report from Fernando Azpiroz, MD, PhD: Understanding Intestinal Gas
2005 Award Recipients
Report from Yvette Tache, PhD: Stress and Irritable Bowel Syndrome: Unraveling the Code
Report from Shaheen Hamdy, MRCP, PhD: Adult Neurogenic Dysphagia -- Disorders and Conditions that Disrupt Swallowing
Report from Michael A. Pezzone, MD, PhD: Chronic Pelvic Pain and the Overlap of Pelvic Pain Disorders
Report from Bridget R. Southwell, PhD: Research into Treatment-Resistant Constipation in Children
Report from Rachel Rosen, MD, MPH: Symptoms Arising from Non-Acid Reflux in Children
2003 Award Recipients
Report from William E. Whitehead, PhD: Summary of Clinical Research Activities
Jyoti N. Sengupta, PhD
Report from Caroline Elder Danda, PhD: Biopsychosocial Perspectives on Assessment and Treatment
Report from Terry Buchmiller-Crair, MD: Using the Fetal Gastrointestinal Tract to Overcome Neonatal Disease
Report from Dan L. Dumitrascu, MD, PhD: The Psychosocial Adjustment to Illness in Irritable Bowel Syndrome
Report from Klaus Bielefeldt, MD, PhD: Understanding Pain and Discomfort in Functional GI Disorders
Research Grants
IFFGD Competitive Grants
2014 IFFGD Idiopathic Gastroparesis Research Grants
Leo Cheng, PhD
Braden Kuo, MD, MSc
Richard McCallum, MD
2008 IFFGD Competitive Research Grants
IFFGD Noncompetitive Grants
Other Research Grant Opportunities
Funding Research
Need for Funding Research
How to Make a Difference
The State of Research at NIH & NIDDK
Clinical Trials & Studies
Guide to Randomized Clinical Trials
Clinical Trials and Studies

2020 Advocacy Event


AdvocacyEventWeb

Thank you for sharing your digestive health stories with Members of Congress in Washington, DC, during IFFGD's 2020 Virtual Advocacy Event.

Your voices have made a positive impact across Capitol Hill. You can continue to make a difference by contacting Congress.

Visit the Event Page

View Advocate Training Materials

 

Give Today

give today

Your GIFT can change a life

Your donations help to fund life-changing research and education about chronic digestive conditions and the critical need for improved treatments.

Together, we make a difference.

Donate online