Status:
COMPLETED
Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
Lead Sponsor:
Entera Health, Inc
Conditions:
HIV-associated Enteropathy
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 gastroint...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT01828593
Start Date
April 1 2013
End Date
September 1 2014
Last Update
June 21 2017
Active Locations (10)
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1
AIDS Research Alliance
Los Angeles, California, United States, 90015
2
Univ of California Davis CARES Clinic
Sacramento, California, United States, 95817
3
Univ of California SF
San Francisco, California, United States, 94110
4
Therafirst
Fort Lauderdale, Florida, United States, 33308