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EnteraGam® IBS-D Clinical Study Results

  • EnteraGam® significantly reduced the number of days patients experienced loose stools and other IBS-D symptoms1
  • Frequency of loose stools was reduced from 5 days a week to 3 days a week (average)1
Decrease in Mean Number of Days With Global IBS-D Symptoms1,*

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 Some people notice management of their condition with EnteraGam® in as little as 2 to 4 weeks2

*Results from a 6-week, randomized, double-blind, placebo-controlled study (N = 66). Subjects received either EnteraGam® 10 g daily (n = 25), 5 g daily (n = 19), or placebo (n = 22). Subjects self-assessed presence and severity of GI symptoms daily using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). Number of days with symptoms was calculated for each 2-week period per subject. Data above represent within-group changes from baseline to end of study among the 15 subjects taking 10 g of EnteraGam® daily (recommended dose is 5 g to 20 g daily). Within the placebo group (soy protein), there was no statistically significant reduction in the number of days with any GI-related symptoms. Study was not powered to demonstrate between-group differences. The findings from this study suggest that EnteraGam® provides for a distinctive nutritional requirement unique for IBS-D patients which could not be provided for by soy protein.

HIV Clinical Study Results
References
  1. Wilson D, Evans M, Weaver E, Shaw AL, Klein GL. Evaluation of serum-derived bovine immunoglobulin protein isolate in subjects with diarrhea-predominant irritable bowel syndrome. Clin Med Insights Gastroenterol. 2013;6:49-60.
  2. EnteraGam [product information]. Ankeny, IA: Entera Health, Inc.; October 2016.

Intended Use

EnteraGam® is a medical food product intended for the dietary management of chronic diarrhea and loose stools. EnteraGam® must be administered under medical supervision.

Important Safety Information:

EnteraGam® contains beef protein: therefore, patients who have an allergy to beef or any other component of EnteraGam® should not take this product. EnteraGam® has not been studied in pregnant women, in women during labor and delivery, or in nursing mothers. The choice to administer EnteraGam® during pregnancy, labor and delivery, or to nursing mothers is at the clinical discretion of the prescribing physician.

EnteraGam® does not contain any milk-derived ingredients such as lactose, casein, or whey. EnteraGam® is gluten-free, dye-free, and soy-free.

Please see full Product Information

To report suspected adverse reactions, contact Entera Health, Inc. at 1-855-4ENTERA (1-855-436-8372), or the FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.