Serum-Derived Bovine Immunoglobulin/Protein Isolate: Postulated Mechanism Of Action For Management Of Enteropathy

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Entera Health, Inc. Announces Study Published Outlining the Mechanism of Action for EnteraGam™ (Bovine Immunoglobulin Isolate)

Entera Health

Entera Health, Inc. announced today a paper entitled, Serum-Derived Bovine Immunoglobulin Protein Isolate: Postulated Mechanism of Action for Management of Enteropathy, authored by Bryon W. Petschow, PhD; Bruce P. Burnett, PhD; Audrey L. Shaw, PhD; Eric M. Weaver, PhD; and Gerald L. Klein, MD has been published in the journal Clinical and Experimental Gastroenterology.

The paper summarizes data from preclinical and clinical studies with serum-derived bovine immunoglobulin/protein isolate (SBI), as well as other immunoglobulin-containing protein concentrates, with a focus on describing the potential mechanisms of action for patients with enteropathy. Recent studies in humans demonstrate that SBI is safe and may improve the nutritional status and gastrointestinal symptoms (e.g., chronic loose and frequent stools, abdominal discomfort, bloating, urgency) in patients with enteropathy associated with diarrhea-predominant IBS (IBS-D) or HIV infection (1,2). While the exact mode of action of SBI in EnteraGam™ is not completely understood for IBS-D and HIV-associated enteropathy, this specially formulated protein mixture has been shown to have a multi-faceted mode of action providing nutritive benefits such as increases in lean body mass, increased utilization and decreased catabolism of protein, decreased fecal fat and energy loss, as well as increased nutrient absorption. SBI in EnteraGam™ has been shown to bind microbial components, manage GI immune balance, maintain gut barrier function, and improve nutrient utilization to provide the distinct nutrition required to manage enteropathy.

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About Enteropathy
Enteropathy is frequently found in association with several human disease conditions, including IBS or HIV infection, and is caused by pathological changes in the lining of the intestinal tract. Such changes disrupt the homeostasis of the GI tract and may lead to symptoms of abdominal pain and discomfort, bloating, and abnormal bowel function (e.g., diarrhea, urgency, constipation). While the pathophysiological mechanisms that lead to enteropathy are not well understood, there is a developing body of evidence to suggest the involvement of genetic or epigenetic predispositions, diet, stress, and exposure to external antigens, toxins, or environmental insults (including infection). Combinations of these trigger factors lead to a continuing cycle of altered gut microbiota, immune dysregulation, gut barrier dysfunction with permeability changes, and nutrient malabsorption, which serves to further amplify and prolong this cycle of events.

About EnteraGam™
EnteraGam™ (serum-derived bovine immunoglobulin/protein isolate, SBI) is a prescription medical food product indicated for the clinical dietary management of enteropathy [e.g., in diarrhea-predominant irritable bowel syndrome (IBS-D) and HIV-associated enteropathy]. EnteraGam™ is required to be used under physician supervision as part of ongoing medical care for a specific condition or disease. EnteraGam™ is also indicated for the clinical dietary management of 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. For full prescribing information, please visit our product website at

Important Safety Information
EnteraGam™ is a specially formulated protein source for the management of intestinal disorders. 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. EnteraGam™ has not been studied in pregnant and nursing mothers. The choice to administer EnteraGam™ in pregnant or nursing mothers is at the clinical discretion 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.

About Entera Health, Inc.
Entera Health, Inc. is focused on improving worldwide health through the development of clinically safe biotherapeutics to address unmet needs. Our passion is to help people thrive through healthier living. Our motivation for conducting basic research, clinical studies, and appropriately educating patients and healthcare providers is driven to meet this goal. Visit us at

1. Wilson D et al. Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects with Diarrhea-Predominant Irritable Bowel Syndrome. Clin MedInsights: Gastroenterol 2013: 6:49-60.
2. Asmuth DM et al. Oral Serum-Derived Bovine Immunoglobulin Improves Duodenal Immune Reconstitution and Absorption Function in Patients with HIV Enteropathy. AIDS 2013;27:2207-17.

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Tom Heck, Chief Operating Officer
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