Digestive Health Research
While progress is being made in our understanding of the gastrointestinal (GI) disorders, important questions remain. For example:
- What causes the disorders?
- Why do certain people get them?
- How do we best treat the conditions?
- How do we prevent the disorders?
- How do we cure them?
Sound medical research is needed to explore these questions.
Here we report a sampling of research studies and medical news that provide clues to better understanding GI disorders. Each new advance adds a small piece to the puzzle, making the big picture clearer.
To learn more about medical research, visit our web site at www.giResearch.org.
Topics - Newest Postings Listed First
- EndoStim LES Stimulation Therapy Shows Promise for GERD Symptoms
- Cellular Abnormalities Discovered in Individuals with Chronic Unexplained Nausea and Vomiting
- Anxiety Associated with Risk of Developing Functional Dyspepsia
- Preliminary Results Announced for CIC Treatment
- Pinaverium Found to Reduce Symptoms of IBS
- Positive Results Announced for EVK-001 for Women with Diabetic Gastroparesis
- Hypnosis Therapy for GERD
- Biomarker Advances for IBS
- A Medical Food may Improve IBS Symptoms
- Medical News Reported at the 2015 DDW Meeting
- Nocturnal GERD Linked to Non-Infectious Rhinitis
- Microbes Linked to the Production of Serotonin
- Homeopathic Medicines to Receive Greater Scrutiny from the FDA?
- New Recommendations Issued by the AGA on the Use of Endoscopes
- Biofeedback Therapy for Bowel Disorders
- New Device Approved by FDA to Treat Silent Reflux
- Individuals with Fibromyalgia at Greater Risk for IBS
- C. difficile Infection in the US
- New Test for Diagnosing Gastroparesis
- Registry Launched for Eosinophilic Gastrointestinal Diseases
- Disease Burden in IBS-C and CIC
- Mesalazine Lacks Effectiveness for Individuals with IBS-D
- Gut-Focused Hypnotherapy an Effective Treatment for IBS
- NIDDK Establishes Office of Nutrition Research
- A Cautious Approach to the Low-FODMAP Diet
- Functional Gastrointestinal Disorders and BMI
- FDA Launches Mobile App to Track Drug Shortages
- Hiatal Hernia and Dyspeptic Symptoms in Children
- Visceral Abdominal Fat Tied to an Increased Risk of IBS-D
- Participants with Diabetic Gastroparesis Sought for Study
- Unhealthy Eating Behaviors and Functional Dyspepsia
- Self-Applied Acupressure for Functional Constipation
- Location of Diverticular Disease and IBS
- Effect of Exercise on the Gut Microbiome and Health
- FDA Approves Generic Version of Nexium for GERD
- FDA Approves Neurostimulator to Treat Symptoms of Gastroparesis
- Treatments are Needed for Functional Dyspepsia
- Maternal Inheritance in Adult Cyclic Vomiting Syndrome
- New Study to Look at Laxative Ingredient Safety in Children
- Fear of IBS Symptoms Impacts Quality of Life
- Gut Microbes in IBS and Chronic Constipation
- Scientists Create Model Human Stomachs to Study Gastric Diseases
- Key Symptoms in Functional Dyspepsia
- Yoga for Young People with IBS
- Preliminary News on Treatments Reported at the 2014 ACG Meeting
- Structure and Functions of the Gut Microbiome
- Integrated Treatments in IBS
- Nortriptyline Lacks Effectiveness in Idiopathic Gastroparesis
- Surveillance of Barrett's Esophagus Reduces Mortality from Esophageal Cancer
- Dietary Elimination Therapy for Eosinophilic Esophagitis
- Biomarkers May Help Predict Risk for Barrett's Esophagus
- FDA Considers Rifaximin for Treatment of IBS-D
- Symptom Episodes in IBS: Consequences for Treatment Procedure
- Statins May Reduce Risk of Barrett's Esophagus
- 6-Year Safety Report of the LINX System for GERD
- Gene Mutation Identified in IBS
- Different Anatomy in Individuals with GERD
- Newer Serotonin Drugs
- GERD or Functional Dyspepsia?
- Microbiota Transplant for Treatment of C. difficile
- Acid Reflux Therapy
- Naloxegol Indicated for Opioid-Induced Constipation
- Authors Call for Standardization of the Decision to Refer for Anti-Reflux Procedures
- IBS and IBD Similarities
- Probiotics in Constipation and IBS
- Targeting IBS Treatment
- Non-Intestinal Symptoms in Childhood Predict IBS in Adulthood
- Foods that Worsen GI Symptoms
- New Guidance on Treatments for Sphincter of Oddi Dysfunction
- Home Parenteral Nutrition for Infants with Ultra-Short Bowel Syndrome
- Restrictive Eating and Abnormal Gut Function
- Guidance Issued in UK for Amitiza in Treating Chronic Idiopathic Constipation
- Results Positive in Study of Rifaximin Repeat Treatment for IBS-D
- Study Underway to Evaluate new Treatment for GERD
- Prevalence of Fructose Malabsorption in Irritable Bowel Syndrome (IBS)
- Chronic constipation associated with increased risk for colorectal tumors
- Bowel Disease A-To-Z Guide Launched In UK
August 11, 2015 – Interim 6-month study results show promise for treatment of gastroesophageal reflux disease (GERD) symptoms using an implanted electrical stimulation device (EndoStim) that targets the lower esophageal sphincter (LES) muscle. The international multicenter trial included 41 patients with GERD symptoms partially responsive to treatment with proton pump inhibitors (PPIs). Long-term, controlled studies are needed to better understand the role of this therapy in treating GERD.
Source: Kappelle WFW, et al. Aliment Pharmacol Ther. July 2015.
August 3, 2015 – A pilot study of 9 individuals with chronic unexplained nausea and vomiting (CUNV) and 9 controls discovered cellular and bioelectrical abnormalities among those with CUNV, including depletion of interstitial cells of Cajal (ICC) – specialized cells found throughout the gastrointestinal (GI) tract required for normal GI motility. These features of CUNV were found to be similar to those of gastroparesis, even though CUNV presents without the abnormal gastric emptying characteristic of gastroparesis.
Identifying the underlying features of CUNV, including overlaps with gastroparesis, could lead to quicker and more confident diagnosis of this condition and the development of better treatments.
Source: Angeli TR, et al. Gastroenterology. August 2015.
July 20, 2015 – A population-based 10-year follow-up study in Sweden of 703 individuals discovered a statistically significant association between anxiety and the development of functional dyspepsia, particularly postprandial distress syndrome (PDS) in which meal-related symptoms of early fullness after a meal typically occur.
Identification of the underlying mechanisms linking anxiety and functional dyspepsia may provide insight into new approaches to reduce or eliminate symptoms.
Source: Aro P, et al. Gastroenterology. May 2015.
July 14, 2015 – Positive results were reported from a Phase 3 randomized controlled study of the investigational drug plecanatide in 1,346 adult patients with chronic idiopathic constipation (CIC) over a 12-week treatment period. A second Phase 3 trial of approximately 2,700 patients with CIC is currently underway to confirm these results.
Source: Business Wire News Release. July 2015.
July 10, 2015 – Results of a randomized, double-blind, controlled clinical trial of the antispasmodic drug pinaverium compared to placebo for the treatment of irritable bowel syndrome (IBS) demonstrated a significant improvement in symptoms, including abdominal pain and discomfort and stool consistency, in 218 individuals with IBS over a period of 4 weeks. The treatment had an acceptable safety profile.
While widely used in many countries around the world, including European countries, Canada, and Mexico, pinaverium is not yet approved for use in the US by the US Food and Drug Administration (FDA).
Source: Zheng L, et al. Clin Gastroenterol Hepatol. 2015 July.
July 7, 2015 – Results of a randomized, double-blind Phase 2b clinical trial of investigational drug EVK-001 (Evoke Pharma), a novel nasal metoclopramide spray, in 285 individuals with diabetic gastroparesis demonstrated a statistically significant improvement in symptoms over 4 weeks, including nausea and upper abdominal pain, in women, but not in men, compared to placebo.
The treatment had an acceptable safety profile, with the most common adverse effects being altered taste, headache, and fatigue. The drug is now being studied in a Phase 3 clinical trial.
Source: Parkman HP, et al. Clin Gastroenterol Hepatol. 2015 July.
June 25, 2015 – A pilot study of 9 mostly female patients with functional heartburn found that esophageal directed hypnotherapy performed weekly over seven weeks was associated with improvement in heartburn symptoms and quality of life, suggesting the use of hypnotherapy in functional heartuburn patients who do not respond to standard drug therapies or who would prefer a non-pharmacologic lifestyle intervention.
Source: Riehl ME, et al. Dis Esophagus. 2015 March.
June 23, 2015 – Two antibodies evident in a blood test appear helpful as biomarkers for differentiating a diagnosis of irritable bowel syndrome (IBS) from inflammatory bowel disease (IBD) in subjects with chronic diarrhea. The antibodies form in people who experience a bout of gastrointestinal (GI) infection (gastroenteritis), and about 10% of these individuals later develop what's termed post-infectious IBS (PI-IBS). It is estimated that 6-17% of people with IBS have PI-IBS.
Source: Pimentel M, et al. PLoS One. 2015 May.
June 23, 2015 – Researchers in a small study that followed 14 patients with various forms of IBS concluded that oral serum-derived bovine immunoglobulin/protein isolate, or SBI (EnteraGam), as a medical food provides a safe option for patients with IBS-D but may have application in other forms of IBS. Twelve of the 14 patients indicated some level of overall improvement within 4 weeks after the addition of SBI to their standard therapy. Learn more
Source: Good L, et al. World J Gastroenterol. 2015 March.
June 9, 2015 – A prospective 10-year study of 5,417 participants found that nighttime gastroesophageal reflux disease (GERD) appears to be a risk factor for non-infectious rhinitis/rhinosinusitis (NIR) when adjusted for other known risk factors such as age, gender, body mass index, tobacco use, and asthma. NIR is associated with symptoms of stuffy nose, runny nose, and/or sneezing in the absence of the common cold.
Given these results the researchers recommend that individuals with rhinitis be assessed for GERD.
Source: Schioler L, et al. Allergy. 2015 March.
June 4, 2015 – Results of a laboratory study suggest that certain bacteria in the gut play an important role in regulating production of the chemical neurotransmitter serotonin. While serotonin is commonly recognized as a signalling molecule in the brain, it is estimated that 90% of the body's serotonin is produced by cells in the gastrointestinal (GI) tract. Altered levels of serotonin in the gut have been linked to several chronic diseases, including irritable bowel syndrome (IBS).
The role that intestinal bacteria play in the function of certain components of the gut nervous system promises to be an exciting direction for future research in the field of functional GI disorders.
Source: Yano JM, et al. Cell. 2015 April.
May 26, 2015 – During a series of public hearings, the US Food and Drug Administration (FDA) took testimony on whether or not it should regulate natural preparations – derived from plants, minerals, and animals – in the same way it does over-the-counter drugs. If the FDA decides in favor of stiffer regulations, homeopathic products would have to demonstrate safety and effectiveness before they could go to market. The FDA would also have the power to review the products' labeling and to reject false or misleading claims.
Currently, homeopathic products are allowed to be sold without pre-market review of approval by the FDA. Over the past several decades, the market for homeopathics has boomed to become a multi-billion dollar industry, and concerns over safety have grown. Since 2009, the FDA has issued almost 40 warning letters regarding the safety of certain homeopathic products.
Source: FDA Public Hearing on Homeopathic Products Regulation Testimony. May 20, 2015.
May 21, 2015 – The American Gastroenterological Association (AGA) has issued best-practices recommendations for physicians on the use of endoscopes, devices used to look inside a body cavity or organ. These recommendations together with the results of an upcoming US Food and Drug Administration (FDA) Medical Devices Advisory Committee meeting with ensure that endoscopes meet a higher level of safety.
Source: AGA Press Releases. March 23, 2015.
May 7, 2015 – A joint American and European medical task force issued a position paper on the usefulness of biofeedback therapy for anorectal disorders. They concluded that, based on the strength of evidence, biofeedback therapy is recommended for short-term and long-term treatment of constipation with dyssynergic defecation and for the treatment of bowel incontinence. Several other specified uses were less strongly supported or not recommended.
The American Neurogastroenterology and Motility Society (ANMS) and the European Society of Neurogasteroenterology and Motility (ESNM) examined available evidence in order to provide the recommendations.
Source: Rao SSC, et al. Neurogastroenterol Motil. 2015 May.
May 4, 2015 – The US Food and Drug Administration (FDA) has approved a non-invasive medical device (Reza Band) to treat symptoms in individuals with silent reflux (also called laryngopharyngeal reflux). Unlike in gastroesophageal reflux disease (GERD), in silent reflux gastric contents are regurgitated into the larynx (often called the "voice box") and the pharynx. The device is worn while sleeping. It works by applying a slight pressure to the area below the Adam's apple, preventing the flow of gastric contents past the upper esophageal sphincter.
Symptoms of silent reflux include bothersome throat problems such as hoarseness, chronic cough, frequent throat clearing, and the sensation that something is stuck in the throat.
Source: FDAnews.com. 2015 March
April 27, 2015 – A study of 33,729 individuals with newly diagnosed fibromylagia and 134,915 healthy controls randomly sampled from the Taiwan National Health Insurance Research Database between the years 2000 and 2011 found that presence of fibromyalgia was a significant risk factor for irritable bowel syndrome (IBS) when controlled for other factors, including sex, age, and the presence of other diseases. Treatment of fibromyalgia with antidepressants was also found to be a risk factor for IBS. Lastly, coexistence of certain other diseases along with fibromyalgia, including chronic liver or kidney disease, depression, anxiety, and sleep disorder was found to significantly increase risk for IBS.
From these findings the researchers suggest that individuals with fibromyalgia should be assessed regularly for other potential risk factors for IBS to reduce incidence.
Source: Yang TY, et al. Medicine. 2015 March.
April 20, 2015 – A 2011 survey estimated an incidence of C. difficile infection in the US of approximately 453,000 during the calendar year. Looking at a total of 15,461 active cases, the investigators found that two-thirds of C. difficile infections occurred in hospitals and nursing homes. Many infections were community-associated, meaning they happened among those who had not been inpatients in a health care facility. Common risk factors for C. difficile included female gender, Caucasian race, and being 65 years of age or older. More cautious prescribing of antibiotics and careful infection control in health care facilities can reduce the risk.
These results support the growing evidence that C. difficile is no longer restricted to hospital and other inpatient settings. Understanding risk factors and patterns of infection is important in infection prevention and treatment planning. This study was performed as part of the US Centers for Disease Control and Prevention (CDC) Emerging Infections Program (EIP).
Source: Lessa FC, et al. N Engl J Med. 2015 February.
April 11, 2015 – In April 2015, the U.S. Food and Drug Administration (FDA) approved a new non-invasive test of delayed gastric emptying to aid in the diagnosis of gastroparesis. Known as the Gastric Emptying Breath Test (GEBT), it can be performed in any clinical setting.
Gastroparesis is a disorder that slows or stops the movement of food from the stomach to the small intestine in the absence of any observable obstruction or blockage.
The GEBT is conducted over a four-hour period after an overnight fast. It is designed to show how fast the stomach empties solids by measuring carbon dioxide in a patient’s breath. Unlike scintigraphy, which uses a small amount of radioactive material to track gastric emptying, the GEBT uses no radioactive emitting material. Scintigraphy is considered the standard of care for measuring gastric emptying.
The safety and effectiveness of the GEBT was studied in 115 participants prior to FDA approval. All participants were tested with both the GEBT and gastric scintigraphy. The GEBT results agreed with scintigraphy results 73-97 percent of the time when measured at various time points during the test.
People with hypersensitivity to Spirulina, egg, milk or wheat allergens should avoid the GEBT. The test also should not be administered to people with certain lung diseases or conditions that cause small bowel malabsorption.
Source: FDA News Release, April 6, 2015
April 10, 2015 – The Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) has announced the launch of a new contact registry for eosinophilic gastrointestinal diseases (EGIDs), including eosinophilic esophagitis, eosinophilic gastroenteritis, and others. These are chronic inflammatory conditions believed to be triggered by food-related allergic hypersensitivity, which can lead to gastrointestinal symptoms.
Funded by the US National Institutes of Health (NIH), the goal of the registry is to provide an international database of contact data collected from patients and their families to CEGIR researchers for use in recruiting participants for new EGID studies. Individuals included in the registry will receive notifications of upcoming research studies for which they may be eligible as well as research updates, advocacy information, and opportunities to contribute to researcher training. The registry is online here.
April 3, 2015 – In a US population-based survey of 328 individuals with constipation predominant irritable bowel syndrome (IBS-C) and 552 individuals with chronic idiopathic constipation (CIC), the researchers found that frequency and severity of symptoms were greater in IBS-C respondents than in respondents with CIC. However, in CIC respondents who also experienced frequent abdominal symptoms, such as pain and bloating, a similar disease burden to IBS-C respondents was evident.
Source: Heidelbaugh JJ, et al. Am J Gastroenterol. 2015 March.
April 3, 2015 – Researchers looked at an anti-inflammatory drug, mesalazine, to see if it would be useful for the treatment of diarrhea predominant irritable bowel syndrome (IBS-D). They found that the drug may improve symptoms in a subset of people with post-infectious IBS (PI-IBS).
The randomized placebo-controlled study included 136 individuals with IBS-D. Thirteen of these had PI-IBS.
Source: Lam C, et al. Gut. 2015 March.
April 3, 2015 – A study in the UK looked at the effectiveness of a gut-directed hypnotherapy technique in 1,000 patients with irritable bowel syndrome (IBS) whose symptoms were not adequately treated by conventional management strategies, such as dietary approaches and medications. The majority of participants improved and researchers concluded that the hypnotherapy relieved a wide range of symptoms, as well as improved quality of life and mood, safely and without side effects.
This therapy can be a helpful addition to conventional treatment measures, such as education, dietary and lifestyle changes, and drug therapy, in the treatment of IBS.
The patients received 12 weekly sessions of one-on-one gut-focused hypnotherapy from therapists at Wythenshawe Hospital, Manchester, UK who were trained and experienced using the technique. A study is ongoing to see if similar results can be achieved in a shorter time.
Source: Miller V, et al. Aliment Pharmacol Ther. 2015 March
March 31, 2015 – This August the NIH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will establish the Office of Nutrition Research. This office will replace the NIH Division of Nutrition Research Coordination (DNRC). The new office will assist in leading a diverse group of offices within the NIH that will be responsible for planning new initiatives in NIH nutrition research. It will also be closely associated with the nutritional sciences grant funding programs in the NIDDK.
NIH, the National Institutes of Health, is the center for all federally-funded biomedical research in the US. The NIH conducts medical research; supports the research of non-federal scientists operating in universities, medical schools, hospitals, and research institutions throughout the country and abroad; helps in the training of researchers; and fosters communication of cutting-edge medical information. The NIDDK is the NIH's largest funder of nutrition research. Access the NIH website at www.nih.gov and the NIDDK website at www.niddk.nih.gov to learn more about all that they are responsible for.
March 26, 2015 – A review of published research looked at food intolerance associated with GI symptoms such as increased intestinal gas, abdominal pain, bloating, or diarrhea. Among the findings was increasing evidence that, for some people, a low FODMAP diet approach may be helpful in functional GI disorders when food intolerance is suspected.
However, there are cautions.
- Measures used in various FODMAP research studies to date are not consistent
- The dietary eliminations should be short-term
- Certain gut microorganisms thought to be beneficial have been noted to be significantly decreased after 4 weeks of a low FODMAP diet
- Nutritional adequacy may be reduced
- The diet must be undertaken with the supervision of an experienced dietician (often a registerd dietician, or RD).
FODMAPs are a group of carbohydrates found in many common foods. The diagnosis of FODMAP intolerance is based on a short term (3–4 weeks) diet to reduce or exclude suspected foods to look for symptom improvement, followed by a gradual reintroduction to establish individual tolerance. It is essential to work with a dietician experienced in food intolerance in order to maintain adequate nutrition, minimize impact on the gut microbiota, and avoid unnecessary dietary restrictions.
Source: Lomer MCE. Aliment Pharmacol Ther. 2014 Dec.
March 20, 2015 – A prospective population-based cohort study of 35,447 individuals over the age of 18 found several significant relationships between body mass index (BMI) and risk for various functional gastrointestinal disorders (FGIDs). In adult females, high BMI was associated with an increased risk for functional diarrhea, and both high and low BMI were found to have a positive relationship with functional dyspepsia. In adult males, low BMI was found to be a risk factor for irritable bowel syndrome (IBS). Additionally, the study revealed significant overlaps in FGID diagnoses among participants, particularly between functional dyspepsia and IBS and functional constipation.
This analysis is part of the Nutrinet-Sante online study which was originally launched in France in 2009 but is still ongoing. For more information (in French) or to participate go to www.etude-nutrinet-sante.fr.
Source: Le Pluart D, et al. Aliment Pharmacol Ther. March 2015.
March 16, 2015 – The US Food and Drug Administration (FDA) has launched an application (app) for mobile platforms to increase public access to information about prescription drug shortages. The app provides real-time information about current drug shortages, resolved shortages, and discontinuations of drugs. Drugs can be searched for by generic or brand name or by therapeutic category.
The app is available for free download by going to this FDA webpage, or in the iTunes store (For iOS) and the Google Play store (for Android) by searching "FDA Drug Shortages".
March 10, 2015 – In a survey of 111 children undergoing upper endoscopy (EGD), presence of hiatal hernia was found to be associated with symptoms of heartburn and regurgitation but not other symptoms commonly described for gastroesophageal reflux (GER) or dyspepsia in children older than 4 years of age. Moreover, no association was found between presence of hiatal hernia and esophagitis.
The results of this study suggest that in children, presence of hiatal hernia represents a risk factor for only limited symptoms.
Source: Scarpato E, et al. J Pediatr Gastroenterol Nutr. December 2014.
March 5, 2015 – A case-controlled study of 336 individuals found that while overall body mass index (BMI) does not appear to be related to irritable bowel syndrome (IBS), abdominal fat deposits and waist circumference were both predictors of a higher risk of diarrhea predominant IBS (IBS-D).
From these findings the authors concluded that abdominal obesity, and not general obesity, represents a risk factor for IBS, especially IBS-D.
Source: Lee CG, et al. Am J Gastroenterol. January 2015.
February 27, 2015 – A clinical study is seeking participants diagnosed with diabetic gastroparesis to assess the safety of a drug (IW-9179) in individuals with diabetic gastroparesis and its effects on the principal gastroparesis symptoms. Find details and study locations on this ClinicalTrials.gov page. The study is sponsored by Ironwood Pharmaceticals.
February 24, 2015 – A survey in China of 1,341 individuals with functional dyspepsia (FD) found that those with FD were more likely to engage in unhealthy eating behaviors, including skipping meals, eating extra meals, and consuming large amounts of sweets and gas-producing foods, than healthy individuals. Moreover, these behaviors among individuals with FD were found to be risk factors for more difficult to treat (refractory) FD.
Source: Jiang SM, et al. J Dig Dis. December 2014.
February 16, 2015 – In a randomized clinical study, individuals with functional constipation who were taught how to apply external pressure (acupressure) to the perineum – the area between the anus and the genitals – in addition to standard therapies reported improved quality of life and bowel function compared with individuals who used only standard treatments. Standard therapies included increased dietary fiber intake, stool softeners, and exercise. A total of 91 people completed the study.
The UCLA researchers suggest that education in perineal self-acupressure, which only takes a few minutes to learn, should be included among other first-line treatments for functional constipation.
Source: Abbott R, et al. J Gen Intern Med. November 2014.
February 10, 2015 – A Japanese study of 1,009 individuals concluded that the location of diverticular disease is associated with a risk of irritable bowel syndrome (IBS). Diverticular disease occurring in the left-sided and bilateral sections of the colon, but not on the right side, was associated with a higher risk of IBS.
Clarifying the specific changes associated with left-sided diverticular disease could provide a better understanding of causes of IBS.
Source: Yamada E, et al. Am J Gastroenterol. December 2014.
February 3, 2015 – Researchers of a case-controlled study of 40 Irish athletes and 46 controls found that individuals who engaged in vigorous exercise had greater gut microbial diversity than those who did not. High diversity of gut microorganisms appears to be linked to decreased intestinal inflammation and improved immune function among other things.
Results of this study suggest that exercise has a beneficial effect on the gut microbiome. However, further investigation is needed to tease apart the effects of exercise from other variables, including diet, in promoting the diversity of gut microbes.
Source: Clarke SF, et al. Gut. December 2014.
January 28, 2015 – The U.S. Food and Drug Administration (FDA) has approved the first generic version of Nexium (esomeprazole magnesium) to treat gastroesophageal reflux disease (GERD) in adults and children aged 1 year and older. Esomeprazole is a proton pump inhibitor (PPI) that works by blocking the site of acid production in a particular cell group in the stomach (parietal cells).
Esomeprazole was first approved to treat GERD by the FDA as Nexium in 2001. It is also approved to reduce the risk for gastric ulcers associated with nonsteroidal anti-inflammatory drugs (NSAIDs), treat H. pylori infection in association with certain antibiotics, and treat conditions where the stomach produces too much acid (such as Zollinger-Ellison syndrome).
January 26, 2015 – The U.S. Food and Drug Administration (FDA) has approved a second-generation neurostimulator device (Enterra II) to treat symptoms of nausea and vomiting in people with gastroparesis when other therapies have failed (refractory). The device is implanted under the skin and delivers a mild electrical pulse to stimulate the smooth muscles of the lower stomach. Enterra was first approved by the FDA in 2000. The new device provides physicians with greater system flexibility and ease of use.
January 16, 2015 – A survey of people with functional dyspepsia (FD) found that, although there is currently no drug approved to treat FD, respondents reported using an array of medications attempting to control symptoms. Moreover, one-half of the 114 respondents reported a willingness to take significant risks with a hypothetical medication that could cure their symptoms.
Better understanding of risk taking behavior can help inform drug development and approval processes as well as individual treatment approaches.
Source: Lacy B, et al. Clin Transl Gastroenterol. January 2015
January 13, 2015 – Researchers identified a higher probability of maternal inheritance of various functional gastrointestinal (GI) disorders in a subset of adults with cyclic vomiting syndrome (CVS) compared with healthy controls (12% compared to 1%).
More research studies to identify potential causes for maternal inheritance pattern in adults are warranted to help understand the underlying mechanisms of functional GI disorders.
Source: Venkatesan T, et al. BMC Gastroenterol. October 2014.
January 8, 2015 – The US Food and Drug Administration (FDA) is funding a new study regarding the safety in children of PEG 3350 – the active ingredient in Miralax and similar generic laxatives. The FDA notes that there is little data on its absorption in children, especially in the very young and chronically constipated. Adverse events in children given the laxative have been reported, but it is not known whether the laxatives are the cause.
PEG 3350 laxatives, which are available over-the-counter, were FDA approved for persons aged 17 and older but never approved for long-term daily use. Talk to your doctor if you have a child who is using one of these laxatives.
Source: Saint Louis C. NY Times. January 2015.
January 5, 2015 – A study of 234 individuals with irritable bowel syndrome (IBS) found fear of gastrointestinal (GI) symptoms of IBS to be strongly associated with reduced quality of life. Fear of symptoms was a stronger predictor of quality of life than symptom severity, personality style, sociodemographic variables, or overall emotional well-being.
Better understanding of the factors contributing to quality of life may help clinicians and patients assess, understand, and respond to changes in quality of life and improve IBS treatment outcomes.
Source: Lackner JM, et al. Am J Gastroenterol. November 2014.
November 17, 2014 – Investigators in a systematic review and analysis combining existing randomized controlled studies (meta-analysis) concluded that for some people, probiotics (beneficial microorganisms) effectively benefit irritable bowel syndrome (IBS) symptoms such as abdominal pain, bloating, and gas.
However, it remains unclear which individual species and strains of probiotics are the most beneficial.
More evidence is also required before the role in IBS is known of prebiotics (which promote growth of probiotics) or synbiotics (which combine probiotics and prebiotics). The effectiveness of all three therapies in chronic idiopathic/functional constipation (CIC) is also lacking and uncertain.
Source: Ford AC, et al. Am J Gastroenterol. October 2014.
November 10, 2014 – Using stem cells from adult donors, scientists have been able to grow pea-sized three-dimensional human stomach models under laboratory conditions. These miniature stomachs were developed to model mechanisms of infection by the bacterium Helicobacter pylori, which can cause gastric symptoms including nausea, bloating, and vomiting and can lead to ulcers and stomach cancer in extreme cases.
These models are expected to provide a valuable experimental model for the study of the development, functioning, and diseases of the human stomach.
Source: McCracken KW, et al. Nature. October 2014.
November 6, 2014 – Researchers of a focus group study confirmed that symptoms corresponding to fullness after meals (postprandial) and early fullness (satiation) are the key symptoms for developing a patient reported outcomes (PRO) instrument for meal-related functional dyspepsia (FD)/postprandial distress syndrome (PDS). This information is useful for creating tools used to measure treatment effectiveness.
Under a program called PROMIS (Patient Reported Outcomes Measurement Information System), funded by the National Institutes of Health (NIH), PRO tools for various conditions are being developed which will help design treatment plans for individuals, improve doctor-patient communication, and manage chronic conditions.
Source: Carbone F, et al. Neurogastroenterol Motil. September 2014.
October 30, 2014 – Researchers concluded that therapy for irritable bowel syndrome (IBS) using Iyengar yoga training – 1.5 hour sessions twice weekly for six weeks – is a safe and beneficial compliment to medical care in young people, particularly young adults.
The randomized controlled study involved an initial total of 51 participants including adolescents (ages 14–17) and young adults (ages 18–26) with IBS or recurrent abdominal pain. Physical functioning improved in adolescents, and IBS symptoms, emotional distress, fatigue, and sleep quality improved in young adults.
Iyengar yoga postures are taught in a sequence to address specific problems by teachers who receive training in anatomy, physiology, and safety.
Source: Evans S, et al. J Pediatr Gastroenterol Nutr. August 2014.
October 21, 2014 – In a published article, researchers describe how the understanding of human gut microbiology has undergone a leap forward over the past decade. The composition and function of the microbiome (the microbial gut community, especially bacteria), although stable over long periods, may be influenced by a number of factors including genetics, mode of birth delivery, age, diet, geographic location, and medical treatments.
Changes in the microbiome structure have been linked to inflammatory, functional, and metabolic disorders such as irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), and obesity. It remains to be known whether these changes are a contributing factor or a result of the disease.
Source: Panda S, et al. Endocr Metab Immune Disord Drug Targets. July 2014.
October 16, 2014 – In a review of IBS treatment studies, investigators summarized the most widely used complementary and alternative medicine (CAM) approaches that have proven effectiveness and have been endorsed by professional organizations. Examples include specific modalities of hypnotherapy, cognitive behavioral therapy, acupuncture, and yoga.
The reviewers encourage the use of both conventional medicine and CAM approaches by doctors in an integrative setting to provide the best outcome and quality of life to affected individuals.
Source: Grundmann O, Saunjoo LY. World J Gastroenterol. January 2014.
October 16, 2014 – Researchers in a randomized controlled clinical trial concluded that, among patients with idiopathic gastroparesis, the use of the antidepressant nortriptyline compared with placebo for 15 weeks did not result in improvement in overall symptoms. These findings do not support the use of nortriptyline for idiopathic gastroparesis.
Gastroparesis remains a challenging syndrome to manage, with few effective treatments and a lack of rigorously controlled trials. Tricyclic antidepressants are often used to treat refractory symptoms of nausea, vomiting, and abdominal pain despite a lack of evidence from well-designed studies for this use.
Source: Parkman HP, et al. JAMA. December 2013.
October 10, 2014 – Researchers in a large study concluded that monitoring individuals with Barrett's esophagus in an endoscopic surveillance program to watch for signs of abnormal tissue (dysplasia) or cancer was associated with lower tumor stages and reduced esophageal cancer-related mortality than those with Barrett's esophagus who did not participate in surveillance.
The study included 10,000 individuals diagnosed in the Netherlands with cancer of the esophagus. Nearly 800 (8%) of these had been diagnosed with Barrett's esophagus prior to the cancer diagnosis. Barrett's esophagus is one of several factors associated with increased risk of developing esophageal cancer. As with all cancers, early detection is critical to improving treatment outcomes. Learn more about Barrett's esophagus here
Source: Verbeek RE, et al. Am J Gastroenterol. August 2014.
October 6, 2014 – A review of existing data of 31 individuals demonstrated that dietary elimination therapy is a safe and effective treatment in adults with eosinophilic esophagitis (EoE). Individuals underwent either a targeted elimination diet that isolated specific food allergies or a more general 6–food elimination diet. Individuals with EoE most frequently reacted to dairy (44%), eggs (44%), wheat (22%), shellfish (11%), legumes (11%), and nuts (11%).
While both diets were difficult for individuals to stick to, the targeted diet had greater success rates. Oral steroids and diet modification are the only therapies currently available for individuals with EoE.
Source: Wolf WA, et al. Clin Gastroenterol Hepatol. August 2014.
September 22, 2014 – A study of 141 mostly white male veterans concluded that a prediction model based on a risk score of circulating levels of several specific substances in the blood (serum biomarkers) in addition to individual demographic and clinical information (age, sex, race, and waist-to-hip ratio as well as gastroesophageal reflux [GER] frequency and duration and H. pylori status) may help identify persons at risk for Barrett's esophagus more accurately than not including the multi-biomarker risk score.
More research is needed to validate these results in the general population and to see if there are additional biomarkers that can be included to improve the predictive value of this model even further.
Source: Thrift AP, et al. Clin Gastroenterol Hepatol. August 2014.
September 19, 2014 – The supplemental new drug application (sNDA) for rifaximin 550 mg has been accepted for review by the U.S. Food & Drug Administration (FDA). Rifaximin is an antibiotic under investigation for the treatment of irritable bowel syndrome with diarrhea (IBS-D). A decision from the FDA regarding the approval status of the drug is expected by Feb 28, 2015. Learn more
September 18, 2014 – A study involving 185 individuals with irritable bowel syndrome (IBS) found that symptoms, including diarrhea, constipation, and abdominal pain, as well as bloating, tend to occur as episodes, over 2–4 days on average, rather than either sporadically or at regular intervals. Roughly half of individuals experienced a mixture of diarrhea and constipation episodes. Episodes of pain were not consistently relieved by a bowel movement or associated with a change in the frequency or consistency of stool.
Better understanding of the nature of episodic symptoms may help doctors and patients improve treatment regimens.
Source: Palsson OS, et al. Am J Gastroenterol. July 2014.
September 9, 2014 – In a study of veterans, statin use was associated with a reduced risk of Barrett's esophagus. Statins are a class of drugs used to lower cholesterol.
This effect was most pronounced in obese individuals and those with a high waist to hip ratio (WHR). The study population included 303 individuals with Barrett's esophagus and 909 controls without Barrett's esophagus.
Source: Nguyen T, et al. Gastroenterology. August 2014.
September 9, 2014 – A safety analysis recently published for the LINX system magnetic sphincter augmentation device (MSAD) for gastroesophageal reflux disease (GERD) reported a low risk profile with no serious events leading to long-term complications associated with the device.
LINX is a surgically implanted device that works by reinforcing the lower esophageal sphincter (LES).
The first 1,000 individuals who underwent the procedure were reevaluated after 6 years. The analysis concluded that the safety profile for the procedure performed by an experienced surgeon establishes it as a viable option for individuals with uncomplicated GERD who are considering antireflux surgery
Source: Lipham JC, et al. Dis Esophagus. June 2014.
September 5, 2014 – A survey of over 500 individuals confirmed a 2.2% prevalence of a mutation in a gene (SCN5A) in individuals with irritable bowel syndrome (IBS), as reported in an earlier pilot study. The SCN5A gene encodes a mechanism (sodium channels) involved in maintaining normal gastrointestinal (GI) motility.
The role of individual genes in symptom generation and expression in IBS remains largely unknown. Identification of these genes and their effects on the structure and function of the GI tract has the potential to reveal the mechanism of IBS in a subset of individuals with the disorder and shed light on new treatment pathways.
Source: Beyder A, et al. Gastroenterology. June 2014.
September 5, 2014 – A study using magnetic resonance imaging (MRI) of 48 people found that those with mild to moderate gastroesophageal reflux disease (GERD) have several anatomical differences relating to the reflux barrier compared to healthy volunteers.
Primary among them, the angle of the esophagus (food tube) into the stomach was found to be wider in individuals with GERD compared with healthy individuals. This angle is an essential part of the way the body prevents reflux, called the "flap valve" mechanism. Also, the opening from the esophagus to the stomach (the esophagogastric junction), a key defense against the reflux of stomach contents after a large meal, was found to open wider in individuals with GERD. Differences in both of these structures in individuals with GERD are suspected to contribute to reflux.
Source: Curcic J, et al. Am J Gastroenterol. May 2014.
August 13, 2014 – Researchers are finding new serotonin drugs that may help treat a variety of functional gastrointestinal (GI) disorders with improved safety.
A new generation of 5-HT4 receptor agonists is useful in treating symptoms of functional constipation, and have an improved safety profile compared to older drugs in this class.
A relatively new serotonin drug to treat irritable bowel syndrome with diarrhea (IBS-D) is also being developed. The drug, ramosetron (a 5HT3 receptor antagonist), has been associated with improved stool consistency in nearly 300 men with IBS-D in Japan. It appears to have an improved safety profile compared to other drugs in this class.
Source: Camilleri M. Neurogastroenterol Motil. August 2014.
August 13, 2014 – In a review of records, researchers at Mayo Clinic found an increase over a two decade period in gastroesophageal reflux disease (GERD) diagnosis rates, but no increase in reported GERD symptoms. About 6 out of 10 persons reporting GERD symptoms received a GERD diagnosis while only about 1 out of 10 persons reporting functional dyspepsia (FD) symptoms received an FD diagnosis.
Common symptoms of GERD – heartburn and/or acid regurgitation – are also reported in about one-third of people with FD. However, treatments differ for these 2 conditions and PPIs that treat GERD do not work for FD.
Source: Pleyer C, et al. Neurogastroenterol Motil. August 2014.
August 12, 2014 – A study involving existing medical information collected on 75 adults and 5 children from 16 different medical centers concluded that fecal microbiota transplant (FMT) appears to be safe and effective for treating C. difficile infection in people who have weakened immune systems.
Up to 15–20% of cases of antibiotic-associated recurrent diarrhea and colitis presented in hospitals are attributed to C. difficile infection. FMT helps restore the balance of beneficial microorganisms lost to antibiotic use, and is indicated for people who have not been helped by standard therapies for C. difficile. However, the use of this treatment among individuals with weakened immune systems has been limited due to concerns about safety.
Source: Kelly CR, et al. Am J Gastroenterol. July 2014.
August 12, 2014 – Proton pump inhibitors (PPIs) reduce stomach acid production and are widely used to treat gastroesophageal reflux disease (GERD). However, in about 30% of patients PPIs do not adequately resolve symptoms.
Researchers looking at the occurrence of acid reflux events concluded that strategies which target the pool of acid (called the acid pocket) that floats on the top of ingested food after a meal may be effective for people with GERD who are not helped by PPIs alone.
Altering the size, position, and acidity of the acid pocket while using a PPI may add therapeutic benefit.
Source: Rohof WO, et al. Clin Gastroenterol Hepatol. July 2014.
August 11, 2014 – In two large phase 3 studies, the drug naloxegol was assessed for safety and efficacy in the treatment of opioid-induced constipation in individuals taking opioids for non-cancer related pain. At daily doses of both 12.5 mg and 25 mg the drug was associated with a significant reduction in constipation symptoms. Side effects were more frequent at higher doses and most often included gastrointestinal (GI) effects (abdominal pain, diarrhea, nausea, and vomiting).
Naloxegol is a member of an emerging class of drugs (peripherally acting µ-opioid receptor antagonists) that decrease the GI side effects of opioids without reducing their painkilling effects. Naloxegol is indicated for use by individuals suffering from opioid-induced constipation who have not responded satisfactorily to standard laxative therapy.
Source: Chey WD, et al. New Engl J Med. June 2014.
August 11, 2014 – No current standards exist regarding decisions by medical professionals to refer children with severe gastroesophageal reflux disease (GERD) for anti-reflux procedures, including surgery. Decisions may be greatly influenced by parental and referring physician opinions. Standardization based on data showing the safety and effectiveness of treatments is recommended by the authors.
Source: Papic JC, et al. Surgery. May 2014.
August 8, 2014 – A review of existing studies of inflammatory bowel disease (IBD) and of irritable bowel syndrome (IBS) found a number of shared factors contributing to both disorders. In some instances these shared factors may involve brain-gut dysfunction, genetics, abnormal microbiota, low-grade inflammation in some IBS patients, and IBS symptoms in some patients with IBD in remission.
Source: Barbara G, et al. Curr Opin Gastroenterol. May 2014.
August 8, 2014 – A review of existing randomized controlled studies aimed to summarize the usefulness of probiotics in health and disease. The researchers concluded that certain strains or combinations may be of benefit in managing constipation and in improving irritable bowel syndrome (IBS) symptoms, among other things. The summary is intended to provide a guide to healthcare providers working with patients.
Source: Taibi A, Comelli EM. Appl Physiol Nutr Metab. May 2014.
August 8, 2014 – Researchers reviewing existing studies found an imbalance of certain cells (cytokines) involved in regulating inflammation and sensitization in people with irritable bowel syndrome (IBS) compared to people without IBS. Using a cytokine profile may eventually be one way to help individualize treatment for people with IBS.
Source: Bashashati M, et al. Neurogastroenterol Motil. May 2014.
August 8, 2014 – Recent findings suggest that symptoms existing outside the intestinal tract, such as reflux, joint pain, skin abnormalities, and psychological dysfunction, in association with childhood functional abdominal pain are significant predictors of the development of functional gastrointestinal disorders, particularly irritable bowel syndrome (IBS), in adulthood.
Source: Horst S, et al. Clin Castroenterol Hepatol. April 2014.
August 8, 2014 – A study of 25 children with functional gastrointestinal (GI) disorders revealed that specific foods are perceived by children to worsen their GI symptoms. These most often included spicy foods, cow’s milk, and pizza. Common coping strategies identified were consuming smaller portions, modifying foods, and avoiding problem foods.
Source: Carlson M, et al. J Acad Nutr Diet. March 2014.
August 8, 2014 – Results of a new study indicate that ERCP and surgery (sphincterotomy) are not reliably effective treatments of pain resulting from sphincter of Oddi dysfunction (SOD). Because these procedures carry substantial risk, the authors do not recommend the continued use of ERCP and sphincterotomy for abdominal pain following cholecystectomy – removal of the gallbladder.
SOD describes a condition in which the sphincter does not relax at the appropriate time, most often due to scarring or muscle spasm. The back-up of digestive juices that results can cause episodes of severe abdominal pain.
Source: Cotton PB, et al. JAMA. May 2014.
August 8, 2014 – Because of the long-term complications associated with intestinal transplantation, the authors in a new study for the treatment of infants with ultra-short bowel syndrome (U-SBS) recommend a non-transplant home parenteral nutrition approach (in the absence of liver disease).
Parenteral nutrition is an intravenous feeding technique that delivers nutrition directly into the blood stream.
Source: Diamanti A, et al. J Ped Gastroenterol Nutr. April 2014.
August 8, 2014 – Results from a preliminary study of adolescents with irritable bowel syndrome (IBS) suggest that frequent bouts of restrictive eating – such as not eating when hungry or eliminating certain foods – are associated with abnormalities in gastric sensation and gut motility. These gastrointestinal symptoms have been noted in association with other conditions characterized by restrictive eating. Results of this study warrant further investigation.
Source: Van Tilburg MAL, et al. J Ped Gastroenterol Nutr. April 2014.
July 23, 2014 – The National Institute for Health and Care Excellence (NICE) has issued guidance on the use of lubiprostone (Amitiza) for treating chronic idiopathic constipation in the United Kingdom. The guidelines stipulate that the drug should only be considered in adults who have tried at least 2 laxatives at the highest tolerated recommended doses for at least 6 months, but who have not seen an improvement in their symptoms.
NICE clinical guidelines are recommendations on the appropriate treatment and care of people with specific diseases and conditions within the National Health Service (NHS) in the UK.
July 1, 2014 – Salix Pharmaceuticals reported positive results from the TARGET 3 – Phase 3 study to evaluate the efficacy and safety of repeat 14 day treatment with rifaximin for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in people who responded to an initial 14 day treatment course with rifaximin. Compared to placebo, subjects treated with rifaximin showed statistically significant improvement in IBS-related abdominal pain and stool consistency during the 4 week treatment-free follow-up period in the double blind repeat treatment phase.
June 30, 2014 – A phase 2 study is underway on a new drug to treat gastroesophageal reflux disease (GERD) in patients not adequately helped by proton pump inhibitors (PPIs). The study will assess the effect of the drug (IW-3718) compared to placebo as an added treatment in GERD patients who will continue to also take a once-daily PPI. Ironwood Pharmaceuticals is developing the drug.
May 28, 2014 – Fructose can trigger or worsen symptoms in irritable bowel syndrome (IBS). A new study investigated the prevalence of symptomatic fructose malabsorption in those with IBS and tested whether any patient characteristics can help to detect fructose malabsorption.
After ingesting 25g of fructose, fructose malabsorption was found in 22% of those studied. Symptoms indicating intolerance to fructose were found in 28% of sampled individuals, not all of whom demonstrated malabsorption. There were no differences in IBS subtype or clinical symptoms between those who did or did not have malabsorption. However, young males had a greater incidence of malabsorption.
The authors recommend further studies to determine whether a low-fructose diet would help IBS patients who are intolerant to fructose, with and without malabsorption.
May 20, 2014 – A retrospective database study of existing records has found that people with diagnoses of severe chronic constipation (CC) have a potentially higher risk of developing colorectal cancer and non-cancerous (benign) colorectal tumors over time, compared to people without CC.
The study, which looked at medical record databases, reviewed data from over 100,000 patients (28,854 patients with CC and 86,562 without) for 2–5 years. In those with CC, 2.7% developed colorectal cancer vs. 1.7% of those without. For non-cancerous colorectal tumors, the proportion was 24.8% for those with CC and 11.9% for those without. The risks increased with the severity of the chronic constipation.
These findings demonstrate an association only – not a causation – between chronic constipation and the development of colorectal cancer and/or benign tumor. While further studies are needed to determine whether there is an underlying causal link, the authors recommend that doctors be aware of this potential association in order to monitor and treat their patients appropriately.
May 09, 2014 – The Association of Coloproctology of Great Britain and Ireland has launched a guide on their website to help patients find expert surgeons. The guide classifies surgeons by location as well as by their interest a large variety of different bowel conditions.
UK residents who need surgery as part of their treatment can use the guide to find a surgeon who specializes in their condition.
The guide can be found here: http://www.acpgbi.org.uk/specialists/