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

Entera Health

Status: Completed

Conditions: HIV-associated Enteropathy

Treatments: Other: Placebo; Other: Serum-derived bovine immunoglobulin protein isolate (SBI)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01828593

EH6001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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103 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching Placebo

Treatment:

Other: Placebo

SBI 2.5 g

Active Comparator group

Description:

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

Treatment:

Other: Serum-derived bovine immunoglobulin protein isolate (SBI)

SBI 5.0g

Active Comparator group

Description:

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

Treatment:

Other: Serum-derived bovine immunoglobulin protein isolate (SBI)