Entera Health, Inc. Announces Study Published Outlining the Mechanism of Action for EnteraGam™ (bovine immunoglobulin isolate)
CARY, NC - (Business Wire June 10, 2014) - 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.
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.
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 http://enteragam.com