Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy

Not Applicable

Completed

• Conditions: HIV-associated Enteropathy
• Interventions: Other: Placebo; Other: Serum-derived bovine immunoglobulin protein isolate (SBI)

• Registration Number: NCT01828593
• Lead Sponsor: Entera Health, Inc

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-04-08
• Study First Posted: 2013-04-10
• Primary Completion: 2014-01
• Study Completion: 2014-09
• Results First Submitted: 2016-02-09
• Results First Submitted QC: 2016-02-09
• Results First Posted: 2016-03-08
• Status Verified: 2017-04
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching Placebo
SBI 5.0g	Serum-derived bovine immunoglobulin protein isolate (SBI)	Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g
SBI 2.5 g	Serum-derived bovine immunoglobulin protein isolate (SBI)	Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g

Primary Outcome Measures

Name	Time	Method
Frequency of Daily Unformed Bowel Movements	Baseline and 4 weeks	Change in number of abnormal or unformed stools by week 4

Trial Locations

Locations (4)

Univ of California Davis CARES Clinic; 🇺🇸 Sacramento, California, United States

Univ of California SF; 🇺🇸 San Francisco, California, United States

AIDS Research Alliance; 🇺🇸 Los Angeles, California, United States

Therafirst; 🇺🇸 Fort Lauderdale, Florida, United States