EnteraGamTM is a new prescription medical food product to help people manage ongoing problems with chronic loose and frequent stools (diarrhea). Medical foods are required to be used under physician supervision as part of ongoing medical care for a specific condition or disease.
EnteraGam is manufactured and distributed by Entera Health, Inc. It is indicated for the clinical dietary management of intestinal disease (enteropathy) in patients who, because of therapeutic or chronic medical needs, have limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients.
The main ingredient in EnteraGam is a specially formulated protein preparation that consists of more than 50 percent of immunoglobulin (molecules involved with immune function). This ingredient, SBI (serum-derived bovine immunoglobulin/protein isolate), is made up of beef serum proteins. The proteins in SBI remain in the intestine and are not absorbed whole. Patients with beef allergy should not take EnteraGam.
July 3, 2015 – Researchers in a small study that followed 14 patients with various forms of IBS (2 IBS-C, 7 IBS-D, 2 IBS-Mixed, and 3 IBS-Undefined) concluded that SBI, oral serum-derived bovine immunoglobulin/protein isolate (EnteraGam), as a medical food provides a safe option for patients with IBS-D, but may also 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. The study results were published in March 2015 in the World Journal of Gastroenterology.
August 21, 2014 – A research review summarizing accumulated data from prior studies reported that specially formulated immunoglobulin sources like SBI, the main ingredient in the prescription medical food EnteraGam, have multiple effects which collectively serve to improve and maintain nutrient utilization, including water balance. This review demonstrates that other protein sources, besides immunoglobulins, do not effect in the management of intestinal disorders (enteropathy) in patients with chronic loose and frequent stools in conditions like irritable bowel syndrome with diarrhea (IBS-D). The mode of action appears to be combined effects on binding microbial components, maintaining immune balance, and managing gut barrier function, which has the result of improving nutrient utilization, including water.
The reviewers concluded that, taken together, results from studies with SBI reveal a distinctive nutritional requirement for immunoglobulins for the purpose of restoring functional homeostasis to aid in the management of enteropathy. This meets a critical requirement that the FDA has for medical foods.
The review study, by Petschow et al, was published in August 2014 in the journal, Digestive Diseases and Sciences. The authors are employed by Entera Health.
Results from a randomized, double-blind, placebo-controlled pilot study enrolling 66 subjects suggest that nutritional therapy with SBI, the ingredient found in EnteraGam – used in addition to traditional medical care – can help manage various symptoms associated with irritable bowel syndrome with diarrhea (IBS-D). The study, by Wilson et al, was published in 2013 in the journal, Clinical Medicine Insights: Gastroenterology.
A total of 45 persons completed the study per the protocol, with 31 in the SBI group and 14 in a placebo group. The symptom profile of each participant was determined during the first week, followed by a 6-week treatment period. Of the subjects who did not complete the study, 5 were lost to follow-up, 3 did not comply with the study requirements, 1 discontinued due to lack of efficacy, 2 were removed at the Principal Investigator’s discretion. The safety profile of SBI in the study was similar to that of placebo. A total of 4 people withdrew, from both the placebo and the SBI groups, due to nausea. No serious adverse events were reported. The proportion of subjects who withdrew was not significantly different between treatment groups.
The study showed that nutritional therapy with either 10 g/day or 5 g/day of SBI in patients was well tolerated and resulted in statistically significant improvements in days with symptoms and a trend for improvement in symptom severity scores in participants with IBS-D. In particular, the 15 participants who received 10g/day of SBI showed significant reductions in abdominal pain, loose stools, bloating, flatulence, and urgency.
The product has been extremely well tolerated for up to a year in HIV patients and up to 8 months in infants. The major side effects in clinical trials (2–5%) have included mild nausea, constipation, stomach cramps, headache, and increased urination.
EnteraGam is contraindicated for patients with a hypersensitivity (allergy) to beef, or any components in EnteraGam. Therefore, patients who have an allergy to beef or any component of EnteraGam should not take this product. The effect of EnteraGam on nursing mothers and the infant is unknown. The choice to administer EnteraGam in pregnant or nursing mothers is up to the clinical decision of the physician.
Medical foods like EnteraGam are required by FDA regulations to be dosed and monitored by physicians as part of ongoing care for patients with chronic conditions or diseases.