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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01828593
First Posted: April 10, 2013
Last Update Posted: June 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Entera Health, Inc
April 8, 2013
April 10, 2013
February 9, 2016
March 8, 2016
June 21, 2017
April 2013
January 2014   (Final data collection date for primary outcome measure)
Frequency of Daily Unformed Bowel Movements [ Time Frame: Baseline and 4 weeks ]
Change in number of abnormal or unformed stools by week 4
Frequency of daily bowel movements [ Time Frame: 4 weeks ]
Complete list of historical versions of study NCT01828593 on ClinicalTrials.gov Archive Site
Not Provided
  • 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 ]
  • 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 ]
Effects of SBI on pro-inflammatory intestinal microbial populations, bacterial translocation, intestinal barrier function, and systemic immune activation [ Time Frame: through 6 months ]
 
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.
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
HIV-associated Enteropathy
  • 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
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
September 2014
January 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01828593
EH6001
No
Not Provided
Plan to Share IPD: No
Entera Health, Inc
Entera Health, Inc
Not Provided
Principal Investigator: David M Asmuth, M.D. University of California, Davis
Entera Health, Inc
April 2017

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