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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 E

Nutrient 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

Page last updated: August 23, 2015

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