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

May 25, 2017 updated by: Entera Health, Inc

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90015
        • AIDS Research Alliance
      • Sacramento, California, United States, 95817
        • Univ of California Davis CARES Clinic
      • San Francisco, California, United States, 94110
        • Univ of California SF
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Therafirst
      • Miami Springs, Florida, United States, 33166
    • Illinois
      • Chicago, Illinois, United States, 600654
    • Massachusetts
      • Boston, Massachusetts, United States, 02461
    • Michigan
      • Detroit, Michigan, United States, 48201
    • Ohio
      • Cincinnati, Ohio, United States, 45206
    • Texas
      • Fort Worth, Texas, United States, 76107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching Placebo
Other: Placebo
Matching placebo
Active Comparator: SBI 2.5 g
Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g
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.
Active Comparator: SBI 5.0g
Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Daily Unformed Bowel Movements
Time Frame: Baseline and 4 weeks
Change in number of abnormal or unformed stools by week 4
Baseline and 4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Peripheral CD4+ T Cell Counts in Lowest Baseline CD4+ Quartile (Less Than or Equal to 418)
Time Frame: Baseline and 4 weeks
Lowest baseline CD4+ quartile (less than or equal to 418)
Baseline and 4 weeks
Change From Baseline in Peripheral CD4+ T Cell Counts in 2nd Baseline CD4+ Quartile (Greater Than 418 and Less Than or Equal to 630
Time Frame: Baseline and 4 weeks
2nd Baseline CD4+ Quartile (greater than 418 and less than or equal to 630)
Baseline and 4 weeks
Change From Baseline in Peripheral CD4+ T Cell Counts in 3rd Baseline CD4+ Quartile (Greater Than 630 and Less Than or Equal to 890)
Time Frame: Baseline and 4 weeks
3rd Baseline CD4+ Quartile (Greater than 630 and Less than or Equal to 893)
Baseline and 4 weeks
Change From Baseline in Peripheral CD4+ T Cell Counts in 4th Baseline CD4+ Quartile (Greater Than 893)
Time Frame: Baseline and 4 weeks
4th Baseline CD4+ Quartile (greater than 893)
Baseline and 4 weeks
Change From Baseline in Duodenal Gut-associated Lymphoid Tissue (GALT) CD4+ T Cell Densities
Time Frame: Baseline and Week 24
Baseline and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Entera Health, Inc

Investigators

  • Principal Investigator: David M Asmuth, M.D., University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

April 8, 2013

First Submitted That Met QC Criteria

April 8, 2013

First Posted (Estimate)

April 10, 2013

Study Record Updates

Last Update Posted (Actual)

June 21, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH6001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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