Back to resultsImpact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
Primary Purpose
HIV-associated Enteropathy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Serum-derived bovine immunoglobulin protein isolate (SBI)
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for HIV-associated Enteropathy
Eligibility Criteria
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)
Sites / Locations
- AIDS Research Alliance
- Univ of California Davis CARES Clinic
- Univ of California SF
- Therafirst
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
SBI 2.5 g
SBI 5.0g
Arm Description
Matching Placebo
Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g
Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g
Outcomes
Primary Outcome Measures
Frequency of Daily Unformed Bowel Movements
Change in number of abnormal or unformed stools by week 4
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01828593
Brief Title
Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
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 Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Entera Health, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-associated Enteropathy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo
Arm Title
SBI 2.5 g
Arm Type
Active Comparator
Arm Description
Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g
Arm Title
SBI 5.0g
Arm Type
Active Comparator
Arm Description
Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g
Intervention Type
Other
Intervention Name(s)
Serum-derived bovine immunoglobulin protein isolate (SBI)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Frequency of Daily Unformed Bowel Movements
Description
Change in number of abnormal or unformed stools by week 4
Time Frame
Baseline and 4 weeks
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Peripheral CD4+ T Cell Counts in Lowest Baseline CD4+ Quartile (Less Than or Equal to 418)
Description
Lowest baseline CD4+ quartile (less than or equal to 418)
Time Frame
Baseline and 4 weeks
Title
Change From Baseline in Peripheral CD4+ T Cell Counts in 2nd Baseline CD4+ Quartile (Greater Than 418 and Less Than or Equal to 630
Description
2nd Baseline CD4+ Quartile (greater than 418 and less than or equal to 630)
Time Frame
Baseline and 4 weeks
Title
Change From Baseline in Peripheral CD4+ T Cell Counts in 3rd Baseline CD4+ Quartile (Greater Than 630 and Less Than or Equal to 890)
Description
3rd Baseline CD4+ Quartile (Greater than 630 and Less than or Equal to 893)
Time Frame
Baseline and 4 weeks
Title
Change From Baseline in Peripheral CD4+ T Cell Counts in 4th Baseline CD4+ Quartile (Greater Than 893)
Description
4th Baseline CD4+ Quartile (greater than 893)
Time Frame
Baseline and 4 weeks
Title
Change From Baseline in Duodenal Gut-associated Lymphoid Tissue (GALT) CD4+ T Cell Densities
Time Frame
Baseline and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Asmuth, M.D.
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
AIDS Research Alliance
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Facility Name
Univ of California Davis CARES Clinic
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Univ of California SF
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Therafirst
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
600654
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02461
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
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