Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
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.
1 other identifier
interventional
103
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2013
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 8, 2013
CompletedFirst Posted
Study publicly available on registry
April 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
March 8, 2016
CompletedJune 21, 2017
April 1, 2017
9 months
April 8, 2013
February 9, 2016
May 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of Daily Unformed Bowel Movements
Change in number of abnormal or unformed stools by week 4
Baseline and 4 weeks
Other Outcomes (5)
Change From Baseline in Peripheral CD4+ T Cell Counts in 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
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)
Baseline and 4 weeks
- +2 more other outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORMatching Placebo
SBI 2.5 g
ACTIVE COMPARATORSerum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g
SBI 5.0g
ACTIVE COMPARATORSerum-derived bovine immunoglobulin protein isolate (SBI)5.0g
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
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
Unknown Facility
Miami Springs, Florida, 33166, United States
Unknown Facility
Chicago, Illinois, 600654, United States
Unknown Facility
Boston, Massachusetts, 02461, United States
Unknown Facility
Detroit, Michigan, 48201, United States
Unknown Facility
Cincinnati, Ohio, 45206, United States
Unknown Facility
Fort Worth, Texas, 76107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director, Clinical Research
- Organization
- Entera Health
Study Officials
- PRINCIPAL INVESTIGATOR
David M Asmuth, M.D.
University of California, Davis
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2013
First Posted
April 10, 2013
Study Start
April 1, 2013
Primary Completion
January 1, 2014
Study Completion
September 1, 2014
Last Updated
June 21, 2017
Results First Posted
March 8, 2016
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share