Clinical trial NCT01828593: Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-associated Enteropathy
Lead sponsor: Entera Health, Inc
Sponsor class: INDUSTRY
First posted: 2013-04-10
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Frequency of Daily Unformed Bowel Movements
timeFrame: Baseline and 4 weeks
Secondary outcomes:
Other outcomes:
measure: Change From Baseline in Peripheral CD4+ T Cell Counts in Lowest Baseline CD4+ Quartile (Less Than or Equal to 418)
timeFrame: Baseline and 4 weeks
measure: Change From Baseline in Peripheral CD4+ T Cell Counts in 2nd Baseline CD4+ Quartile (Greater Than 418 and Less Than or Equal to 630
timeFrame: Baseline and 4 weeks
measure: Change From Baseline in Peripheral CD4+ T Cell Counts in 3rd Baseline CD4+ Quartile (Greater Than 630 and Less Than or Equal to 890)
timeFrame: Baseline and 4 weeks
measure: Change From Baseline in Peripheral CD4+ T Cell Counts in 4th Baseline CD4+ Quartile (Greater Than 893)
timeFrame: Baseline and 4 weeks
measure: Change From Baseline in Duodenal Gut-associated Lymphoid Tissue (GALT) CD4+ T Cell Densities
timeFrame: Baseline and Week 24
Locations:
city: Los Angeles
country: United States
facility: AIDS Research Alliance
state: California
city: Sacramento
country: United States
facility: Univ of California Davis CARES Clinic
state: California
city: San Francisco
country: United States
facility: Univ of California SF
state: California
city: Fort Lauderdale
country: United States
facility: Therafirst
state: Florida
city: Miami Springs
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Cincinnati
country: United States
state: Ohio
city: Fort Worth
country: United States
state: Texas
Study officials:
affiliation: University of California, Davis
name: David M Asmuth, M.D.
role: PRINCIPAL_INVESTIGATOR
References: