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OpenTrials
Completed

NCT Number: NCT01828593

Impact of SBI, a Medical Food, on Nutritional Status in Patients 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.

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Key information

Conditions

HIV-associated Enteropathy Blood-Borne Infections Communicable Diseases Digestive System Diseases Gastrointestinal Diseases Genital Diseases HIV Enteropathy HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Intestinal Diseases Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AIDS Research Alliance, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Serum-derived bovine immunoglobulin protein isolate (SBI)

Other

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.

Placebo

Other

Matching placebo

Primary outcomes

  1. Frequency of Daily Unformed Bowel Movements

    Time frame: Baseline and 4 weeks

    Change in number of abnormal or unformed stools by week 4

Other outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. Change From Baseline in Duodenal Gut-associated Lymphoid Tissue (GALT) CD4+ T Cell Densities

    Time frame: Baseline and Week 24

Sponsors and collaborators

Lead sponsor

Entera Health, Inc

Industry

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 10, 2013
Registry last updated
Jun 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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