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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV-associated Enteropathy
- Sponsor
- Entera Health, Inc
- Enrollment
- 103
- Locations
- 4
- Primary Endpoint
- Frequency of Daily Unformed Bowel Movements
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •History of HIV-1 infection
- •Plasma HIV viral load ≤40 copies/mL
- •Maintained virologic suppression for 1 year
- •Stable Antiretroviral Therapy (ART) regimen
- •History of HIV-associated diarrhea defined as abnormal passage of 3 or more unformed stools per day or a liquid stool volume greater than 200 g per day for at least 4 weeks duration
Exclusion Criteria
- •Positive stool test for pathogenic bacteria, C. difficile or ova and parasites
- •Conditions that require chronic therapy that is known to alter gut microbiota
- •Antibiotics within 2 weeks of screening (exception: prophylaxis antibiotics)
Outcomes
Primary Outcomes
Frequency of Daily Unformed Bowel Movements
Time Frame: Baseline and 4 weeks
Change in number of abnormal or unformed stools by week 4