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

Completed · Not applicable · Has a placebo group

Conditions studied: HIV-associated Enteropathy

In brief

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.

Key facts

Study ID

NCT01828593

Run by

Entera Health, Inc

People needed

103

Starts

2013-04-01

Expected to finish

2014-09-01

Last updated by the study team

2017-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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
• Study site — Miami Springs, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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