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

Entera Health, Inc103 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

103

Conditions

HIV-associated Enteropathy

Interventions

Serum-derived bovine immunoglobulin protein isolate (SBI)OTHER

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.

PlaceboOTHER

Matching placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (10)

AIDS Research Alliance

Los Angeles, California, United States

Univ of California Davis CARES Clinic

Sacramento, California, United States

Univ of California SF

San Francisco, California, United States

Therafirst

Fort Lauderdale, Florida, United States

Outcomes

Primary Outcomes

Frequency of Daily Unformed Bowel Movements

Change in number of abnormal or unformed stools by week 4

Time frame: Baseline and 4 weeks

Data from ClinicalTrials.gov

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