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EnteraGam® Mechanism of Action (MOA)

To best explain how EnteraGam® works, we start with a review of the factors that can cause chronic diarrhea and loose stools in patients with specific intestinal disorders.

Watch the animation to the right or click on the expand arrow on either of the sections below to learn more.

References
  1. Torrallardona D. Spray dried animal plasma as an alternative to antibiotics in weanling pigs—a review. Asian-Aust. J. Anim. Sci. 2010;23(1):131-148.
  2. 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.
  3. Lembcke JL, Peerson JM, Brown Acceptability, safety, and digestibility of spray-dried bovine serum added to diets of recovering malnourished children. J Pediatr Gastroenterol Nutr. 1997;25(4):381-384.
  4. Good L, Panas R. Case Series Investigating the Clinical Practice Experience of Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI) in the Clinical Management of Patients with Inflammatory Bowel Disease. J Gastrointest Syst. 2015;5(2)1-5.
  5. Shafran I, Burgunder P, Wei D, Young HE, Klein G, Burnett BP. Management of inflammatory bowel disease with oral serum-derived bovine immunoglobulin. Therap Adv Gastroenterol. 2015;8(6):331-339.
  6. Awad A, Jasion VS. Use of a Nutritional Therapy, Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI), to Achieve Improvement in Two Different Cases of Colitis. J Gastrointest Syst. 2015;5(2)1-5.
  7. Beauerle B, Burnett B, Dryden G. Successful management of refractory ulcerative colitis with orally administered serum-derived bovine immunoglobulin therapy. Clin Case Rep Rev. 2015;1(4): 90-92.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. EnteraGam [product information]. Ankeny, IA: Entera Health, Inc.; October 2016.
  16. 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.