Dietary Requirement for Serum-Derived Bovine Immunoglobulin (SBI) in the Clinical Management of Patients with Enteropathy

Entera Health, Inc. Announces Manuscript to Be Published Describing a Distinct Nutritional Need for SBI in Patients Who Suffer from Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D).

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Entera Health

Cary, NC (PRWEB) August 19, 2014

Entera Health, Inc. announced today a new manuscript to be published in the journal Digestive Diseases and Sciences (Springer) on how EnteraGam™ (serum-derived bovine immunoglobulin/protein isolate, SBI) provides for a nutritional requirement for patients who suffer from enteropathy associated with diarrhea-predominant irritable bowel syndrome (IBS-D) or infection with the human immunodeficiency virus (HIV). Authors include Bryon Petschow, PhD; Bruce J. Burnett, PhD; Audrey L. Shaw, PhD; Eric M. Weaver, PhD; and Gerald L. Klein MD (1).

This review article summarizes recent publications and provides insight on the interactions of various factors associated with the gastrointestinal tract that impact nutritional status in patients with enteropathy and contribute to the pathophysiology of IBS-D. Studies in humans provide evidence that EnteraGam™ is safe and improves nutritional status and gastrointestinal symptoms in patients with enteropathy associated with irritable bowel syndrome (IBS) (2). The review summarizes studies showing the impact of enteropathy on nutritional status and how specially formulated bovine immunoglobulins may help restore intestinal homeostasis and nutritional status in patients with specific enteropathies. Such protein preparations may provide distinct nutritional support required for the dietary management of patients who, because of therapeutic or chronic medical needs, have limited or impaired capacity to digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or other special medically determined nutrient requirements that cannot be satisfied by changes to the normal diet alone.

An expert panel of well-known academic gastroenterologists will be publishing a paper on how EnteraGam™ supplies a specific nutrient needed to help those patients who suffer from IBS-D and enteropathy in the near future.

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 lead to symptoms of abdominal pain and discomfort, bloating, and abnormal bowel function (e.g., diarrhea, urgency, constipation). While the precise mechanisms that lead to enteropathy are not well understood, combinations of trigger factors (e.g. diet, stress, exposure to external antigens, environmental insults including infection) are believed to develop into 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.

For Current Nutritional Research on EnteraGam™ in IBS-D, please visit: http://clinicaltrials.gov/ct2/show/NCT02163213?term=sbi+ibs-d&rank=1.

The study’s purpose is to evaluate the safety and effectiveness of oral nutritional therapy Serum-Derived Bovine Immunoglobulin (SBI) on nutritional status, amino acid metabolism, bile acid synthesis, epithelial barrier function, and mucosal expression of pivotal genes including tight junction, secretory mechanisms, tissue repair proteins and chemokines in subjects with IBS-D.

Principal Investigator: Michael Camilleri, Mayo Clinic, Rochester Minnesota

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 http://enteragam.com/.

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 http://www.enterahealth.com/.

For questions, please contact:
Tom Heck, Chief Operating Officer
515-963-7560
tom(dot)heck(at)enterahealth(dot)com

Citations:
1. Petschow BW, Burnett BP, Shaw AL, Weaver EM, Klein GL. Dietary requirement for serum-derived bovine immunoglobulins in the clinical management of patients with enteropathy. Dig Dis Sci. 2014; DOI 10.1007/s10620-014-3322-0
2. 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.


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