Impact of Serum-derived Bovine Immunoglobulin Protein Isolate, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Entera Health, Inc
ClinicalTrials.gov Identifier:
NCT01828593
First received: April 8, 2013
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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 BID and SBI 5.0 g versus placebo on supporting nutrient absorption in HIV+ subjects with HIV-associated enteropathy.


Condition Intervention
HIV-associated Enteropathy
Other: Serum-derived bovine immunoglobulin protein isolate (SBI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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.

Resource links provided by NLM:


Further study details as provided by Entera Health, Inc:

Primary Outcome Measures:
  • Frequency of daily unformed bowel movements [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma concentration of Vitamin D and E [ Time Frame: through 6 months ] [ Designated as safety issue: No ]
  • Nutrient absorption [ Time Frame: through 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Daily stool consistency [ Time Frame: through 6 months ] [ Designated as safety issue: No ]
  • Gastrointestinal symptoms [ Time Frame: through 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Effects of SBI on pro-inflammatory intestinal microbial populations, bacterial translocation, intestinal barrier function, and systemic immune activation [ Time Frame: through 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: April 2013
Estimated Study Completion Date: September 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of HIV-1 infection
  • Plasma HIV viral load ≤40 copies/mL
  • Maintained virologic suppression for 1 year
  • Stable 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828593

Locations
United States, California
AIDS Research Alliance
Los Angeles, California, United States, 90015
Univ of California Davis CARES Clinic
Sacramento, California, United States, 95817
Univ of California SF
San Francisco, California, United States, 94110
United States, Florida
Therafirst
Fort Lauderdale, Florida, United States, 33308
Miami Springs, Florida, United States, 33166
United States, Illinois
Chicago, Illinois, United States, 600654
United States, Massachusetts
Boston, Massachusetts, United States, 02461
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Ohio
Cincinnati, Ohio, United States, 45206
United States, Texas
Ft. Worth, Texas, United States, 76107
Sponsors and Collaborators
Entera Health, Inc
Investigators
Principal Investigator: David M Asmuth, M.D. University of California, Davis
  More Information

No publications provided

Responsible Party: Entera Health, Inc
ClinicalTrials.gov Identifier: NCT01828593     History of Changes
Other Study ID Numbers: EH6001
Study First Received: April 8, 2013
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Intestinal Diseases
HIV Enteropathy
Gastrointestinal Diseases
Digestive System Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014