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

Study Overview
=================
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.

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.

Conditions
-----------------
HIV-associated Enteropathy

Intervention / Treatment
-----------------
* Other: Serum-derived bovine immunoglobulin protein isolate (SBI)
* Other: Placebo


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Matching Placebo | Other: Placebo<br>* Matching placebo<br>|
| Active Comparator: SBI 2.5 g<br>Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g | Other: Serum-derived bovine immunoglobulin protein isolate (SBI)<br>* 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.<br>|
| Active Comparator: SBI 5.0g<br>Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g | Other: Serum-derived bovine immunoglobulin protein isolate (SBI)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Daily Unformed Bowel Movements | Change in number of abnormal or unformed stools by week 4 | Baseline and 4 weeks |