Impact of Serum-derived Bovine Immunoglobulin Protein Isolate, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy

HIV-associated Enteropathy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828593
• Other study ID #: EH6001
• Status: Completed
• Phase: N/A
• First received: April 8, 2013
• Last updated: February 9, 2016
• Start date: April 2013
• Est. completion date: September 2014

Study information

• Verified date: February 2016
• Source: Entera Health, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: September 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

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

Related Conditions & MeSH terms

• HIV Enteropathy
• HIV-associated Enteropathy
• Intestinal Diseases

Intervention

Other:
• Serum-derived bovine immunoglobulin protein isolate (SBI)
SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
• Placebo

Locations

Country	Name	City	State
United States	Therafirst	Fort Lauderdale	Florida
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Entera Health, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Peripheral CD4+ T Cell Counts in Lowest Baseline CD4+ Quartile (Less Than or Equal to 418)		4 weeks	No
Other	Change From Baseline in Peripheral CD4+ T Cell Counts in Lowest Baseline CD4+ Quartile (Less Than or Equal to 418)		6 months	No
Other	Change From Baseline in Duodenal Gut-associated Lymphoid Tissue (GALT) CD4+ T Cell Densities in Biopsy Subjects		6 months	No
Primary	Frequency of Daily Unformed Bowel Movements	Change in number of abnormal or unformed stools by week 4	4 weeks	No