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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.
The purpose of the study is to evaluate the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g twice a day (BID) and SBI 5.0 g versus placebo on supporting nutrient absorption in HIV+ subjects with HIV-associated enteropathy.
This study is evaluating 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
AIDS Research Alliance
Los Angeles, California, United States
Univ of California Davis CARES Clinic
Sacramento, California, United States
Univ of California SF
San Francisco, California, United States
Therafirst
Fort Lauderdale, Florida, United States
Miami Springs, Florida, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Cincinnati, Ohio, United States
Fort Worth, Texas, United States
Start Date
April 1, 2013
Primary Completion Date
January 1, 2014
Completion Date
September 1, 2014
Last Updated
June 21, 2017
103
ACTUAL participants
Serum-derived bovine immunoglobulin protein isolate (SBI)
OTHER
Placebo
OTHER
Lead Sponsor
Entera Health, Inc
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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