Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Study Evaluating the Impact of Serum-Derived Bovine Immunoglobulin Protein Isolate, a Medical Food, on Nutritional Status in HIV+ Subjects with HIV-Associated Enteropathy

Investigator: Ma Somsouk, MD, MAS
Sponsor: Entera Health, Inc.

Location(s): United States


This study evaluates the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5g BID and SBI 5.0g compared to placebo for 6 months on gastrointestinal symptoms, nutritional status and quality of life in HIV+ subjects with HIV-associated enteropathy. In addition, the effects of SBI on pro-inflammatory intestinal microbial populations, bacterial translocation, intestinal barrier function, and systemic immune activation will be investigated.