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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV-associated Enteropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Matching Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Matching placebo

SBI 2.5 g

Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g

Group Type ACTIVE_COMPARATOR

Serum-derived bovine immunoglobulin protein isolate (SBI)

Intervention Type 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.

SBI 5.0g

Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g

Group Type ACTIVE_COMPARATOR

Serum-derived bovine immunoglobulin protein isolate (SBI)

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Placebo

Matching placebo

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No