Impact of Serum-derived Bovine Immunoglobulin Protein Isolate, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
Information source: Entera Health, Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV-associated Enteropathy
Intervention: Serum-derived bovine immunoglobulin protein isolate (SBI) (Other)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Entera Health, Inc Official(s) and/or principal investigator(s): David M Asmuth, M.D., Principal Investigator, Affiliation: University of California, Davis
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 BID and SBI 5. 0 g versus
placebo on supporting nutrient absorption in HIV+ subjects with HIV-associated enteropathy.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Frequency of daily unformed bowel movements
Secondary outcome: Plasma concentration of Vitamin D and ENutrient absorption 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) Daily stool consistency Gastrointestinal symptoms
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- History of HIV-1 infection
- Plasma HIV viral load ≤40 copies/mL
- Maintained virologic suppression for 1 year
- Stable 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)
Locations and Contacts
AIDS Research Alliance, Los Angeles, California 90015, United States
Univ of California Davis CARES Clinic, Sacramento, California 95817, United States
Univ of California SF, San Francisco, California 94110, United States
Therafirst, Fort Lauderdale, Florida 33308, United States
Miami Springs, Florida 33166, United States
Chicago, Illinois 600654, United States
Boston, Massachusetts 02461, United States
Detroit, Michigan 48201, United States
Cincinnati, Ohio 45206, United States
Ft. Worth, Texas 76107, United States
Additional Information
Starting date: April 2013
Last updated: March 10, 2014
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