N/A
N=103
Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
HIV-associated Enteropathy
Bottom Line
View on ClinicalTrials.gov: NCT01828593 ↗Enrolled (actual)
103
Serious AEs
2.9%
Results posted
Mar 2016
Primary outcome: Primary: Frequency of Daily Unformed Bowel Movements — -2.46; -2.16; -2.20 abnormal or unformed stools
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Serum-derived bovine immunoglobulin protein isolate (SBI) (Other); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Entera Health, Inc
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Daily Unformed Bowel Movements |
-2.46; -2.16; -2.20 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT01828593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.