Overview

This trial is active, not recruiting.

Condition hiv-associated enteropathy
Treatment serum-derived bovine immunoglobulin protein isolate (sbi)
Sponsor Entera Health, Inc
Start date April 2013
End date January 2014
Trial size 90 participants
Trial identifier NCT01828593, EH6001

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 BID and SBI 5.0 g versus placebo on supporting nutrient absorption in HIV+ subjects with HIV-associated enteropathy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Placebo Comparator)
(Active Comparator)
Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g
serum-derived bovine immunoglobulin protein isolate (sbi)
SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
(Active Comparator)
Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g
serum-derived bovine immunoglobulin protein isolate (sbi)
SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.

Primary Outcomes

Measure
Frequency of daily unformed bowel movements
time frame: 4 weeks

Secondary Outcomes

Measure
Plasma concentration of Vitamin D and E
time frame: through 6 months
Nutrient absorption
time frame: through 6 months
Body measurements: weight, mid-upper arm circumference (MUAC), waist:hip ratio, body mass index (BMI), total body water (TBW), fat-free mass (FFM), body cell mass (BCM)
time frame: through 6 months
Daily stool consistency
time frame: through 6 months
Gastrointestinal symptoms
time frame: through 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - History of HIV-1 infection - Plasma HIV viral load ≤40 copies/mL - Maintained virologic suppression for 1 year - Stable 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)

Additional Information

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.
Principal investigator David M Asmuth, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Entera Health, Inc.