The product information provided in this site is intended for residents of the United States.

What Is EnteraGam®?

EnteraGam® has been shown in studies of mechanism to1-8:

  • Bind microbial components
  • Maintain gastrointestinal (GI) immune balance
  • Manage gut barrier function
  • Improve nutrient utilization

EnteraGam® has been shown in clinical studies to improve GI nutrient absorption, maintain GI immune balance, and manage gut barrier function in the intestine,1-8 all of which have an effect on the patient’s ability to utilize food and certain nutrients as well as effect fluid balance.

Chronic intestinal disorders associated with chronic diarrhea and loose stools, such as irritable bowel syndrome (IBS), induce a “distinct nutritional requirement” for dietary immunoglobulins to maintain homeostasis (balance) in the GI tract. In a clinical trial comparing EnteraGam® to a vegetable protein source, EnteraGam® was shown to significantly reduce the number of days patients experienced loose stools and other diarrhea-predominant IBS (IBS-D) related symptoms.9

EnteraGam® is a medical food* product that provides dietary management for patients with chronic diarrhea and loose stools due to specific intestinal disorders, such as IBS-D and IBD.

*Medical foods are regulated by the FDA under the Orphan Drug Act10; specially formulated to be consumed or administered orally or enterally; to be used under physician supervision as part of ongoing care to ensure proper, safe use; specifically for management of distinctive nutrient needs, resulting from a specific chronic condition or disease; and specially formulated and processed, as results are not achievable by normal dietary intake.

References
  1. Horgan A, Maas K, Henderson A, Detzel C, Weaver E. Serum-derived bovine immunoglobulin/protein isolate binds to microbe-associated molecular patterns. Poster presented at: Federation of American Societies for Experimental Biology; 2014; Washington, DC.
  2. Asmuth D, Netanya S. Utay NS, Somsouk M, et al. Oral bovine immunoglobulin reduces immune activation in HIV+ immune nonresponders. Poster presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 22-25, 2016; Boston, MA.
  3. Petschow BW, Burnett B, Shaw AL, Weaver EM, Klein Serum-derived bovine immunoglobulin/protein isolate: postulated mechanism of action for management of enteropathy. Clin Exp Gastroenterol. 2014;7:181-190.
  4. Henderson AL, Brand MW, Darling RJ, et al. Attenuation of colitis by serum-derived bovine immunoglobulin/protein isolate in a defined microbiota mouse model. Dig Dis Sci. 2015;60(11):3293-3303.
  5. Pérez-Bosque A, Miró L, Maijó M, et al. Dietary intervention with serum-derived bovine immunoglobulins protects barrier function in a mouse model of colitis. Am J Physiol Gastrointest Liver Physiol. 2015;308(12):G1012-G1018.
  6. Pérez-Bosque A, Miró L, Maijó M, et al. Oral serum-derived bovine immunoglobulin/protein isolate has immunomodulatory effects on the colon of mice that spontaneously develop colitis. PLoS One. 2016;11(5):e0154823.
  7. Detzel CJ, Horgan A, Henderson AL, Petschow BW, Warner CD, Maas KJ, Weaver EM. Bovine immunoglobulin/protein isolate binds pro-inflammatory bacterial compounds and prevents immune activation in an intestinal co-culture model. PLoS One. 2015;10(4):e0120278.
  8. EnteraGam [product information]. Ankeny, IA: Entera Health, Inc.; October 2016.
  9. 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.
  10. FDA Website. Orphan Drug Act. http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/medicalfoods/default.htm. Updated May 12, 2016. Accessed February 4, 2017.

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.