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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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+ Su

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 Summary: 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.
Sponsor: Entera Health, Inc

Current Primary Outcome: Frequency of Daily Unformed Bowel Movements [ Time Frame: Baseline and 4 weeks ]

Change in number of abnormal or unformed stools by week 4


Original Primary Outcome: Frequency of daily bowel movements [ Time Frame: 4 weeks ]

Current Secondary Outcome:

Original Secondary Outcome:

  • Plasma concentration of Vitamin D and E [ Time Frame: through 6 months ]
  • Nutrient absorption [ Time Frame: through 6 months ]
  • Body measurements: weight, mid-upper arm circumference (MUAC), waist:hip ratio, body mass index (BMI), total body water (TBW), fat-free mass (FFM), body cell mass (BCM) [ Time Frame: through 6 months ]
  • Daily stool consistency [ Time Frame: through 6 months ]
  • Gastrointestinal symptoms [ Time Frame: through 6 months ]


Information By: Entera Health, Inc

Dates:
Date Received: April 8, 2013
Date Started: April 2013
Date Completion:
Last Updated: December 22, 2016
Last Verified: December 2016