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

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ClinicalTrials.gov Identifier: NCT01828593
Recruitment Status : Completed
First Posted : April 10, 2013
Results First Posted : March 8, 2016
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Entera Health, Inc

Tracking Information
First Submitted Date  ICMJE April 8, 2013
First Posted Date  ICMJE April 10, 2013
Results First Submitted Date  ICMJE February 9, 2016
Results First Posted Date  ICMJE March 8, 2016
Last Update Posted Date June 21, 2017
Study Start Date  ICMJE April 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2016)
Frequency of Daily Unformed Bowel Movements [ Time Frame: Baseline and 4 weeks ]
Change in number of abnormal or unformed stools by week 4
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2013)
Frequency of daily bowel movements [ Time Frame: 4 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2013)
  • Plasma concentration of Vitamin D and E [ Time Frame: through 6 months ]
  • Nutrient absorption [ Time Frame: through 6 months ]
  • 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) [ Time Frame: through 6 months ]
  • Daily stool consistency [ Time Frame: through 6 months ]
  • Gastrointestinal symptoms [ Time Frame: through 6 months ]
Current Other Pre-specified Outcome Measures
 (submitted: May 25, 2017)
  • 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)
  • 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)
  • 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)
  • 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)
  • Change From Baseline in Duodenal Gut-associated Lymphoid Tissue (GALT) CD4+ T Cell Densities [ Time Frame: Baseline and Week 24 ]
Original Other Pre-specified Outcome Measures
 (submitted: April 8, 2013)
Effects of SBI on pro-inflammatory intestinal microbial populations, bacterial translocation, intestinal barrier function, and systemic immune activation [ Time Frame: through 6 months ]
 
Descriptive Information
Brief Title  ICMJE Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE HIV-associated Enteropathy
Intervention  ICMJE
  • 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.
  • Other: Placebo
    Matching placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Matching Placebo
    Intervention: Other: Placebo
  • Active Comparator: SBI 2.5 g
    Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g
    Intervention: Other: Serum-derived bovine immunoglobulin protein isolate (SBI)
  • Active Comparator: SBI 5.0g
    Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g
    Intervention: Other: Serum-derived bovine immunoglobulin protein isolate (SBI)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2016)
103
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2013)
90
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01828593
Other Study ID Numbers  ICMJE EH6001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Entera Health, Inc
Study Sponsor  ICMJE Entera Health, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David M Asmuth, M.D. University of California, Davis
PRS Account Entera Health, Inc
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP