Randomized Placebo-controlled Pilot Trial of Prebiotics+Glutamine in HIV Infection (MicroVIH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sergio Serrano-Villar, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT01838915
First received: April 22, 2013
Last updated: August 2, 2013
Last verified: August 2013

April 22, 2013
August 2, 2013
June 2011
August 2013   (final data collection date for primary outcome measure)
  • Safety [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Adverse events monitoring during the intervention
  • Changes in markers of bacterial translocation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Soluble CD14 and increasing permeability binding protein.
  • Changes in markers of immunoactivation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Changes in percentages of CD4+ and CD8+ T-cells expressing CD25, HLADR, CD38.
  • Changes in inflammatory markers [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Changes in interleukine-6 and high-sensitivity C Reactive Protein
  • Changes in markers of endothelial dysfunction [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Changes in asymmetric dimethylarginine and flow-mediated dilation
  • Changes in gut microbiota composition [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Changes in gut microbiota as determined by 454 pyrosequencing.
Same as current
Complete list of historical versions of study NCT01838915 on ClinicalTrials.gov Archive Site
  • Changes in gut microbiota [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Changes in gut microbiota by 454 pyrosequencing of fecal samples.
  • Disease progression in HIV-infected patients. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Levels of CD4+ T-cell and HIV-1 RNA copies/mL
  • Thymic function [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Gene expression in peripheral blood monocytic cells. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Randomized Placebo-controlled Pilot Trial of Prebiotics+Glutamine in HIV Infection
Gut Microbiota, Bacterial Translocation, Immune Activation and Endothelial Dysfunction in HIV Infection

A rapid and almost complete loss of CD4+ T cells from the gut associated lymphoid tissue (GALT) occurs early in HIV infection, with a permanent damage in the intestinal barrier, changes in gut microbiota, increased bacterial translocation and persistent immune activation, changes that are not restored after the initiation of antiretroviral therapy. The investigators hypothesize than an intervention targetting the enterocyte barrier and the gut microbiota might modify the gastrointestinal tract towards a bifidogenic microbiota and improve markers of bacterial translocation, inflammation, immune activation and endothelial dysfunction.

This is a randomized placebo-controlled clinical trial to evaluate the safety and effectiveness to modify gut microbiota, bacterial translocation, immune activation and markers of endothelial dysfunction of a dietary supplement (prebiotics + glutamine) during a period of six weeks. The study will enroll four cohorts: 1) HIV-infected, treatment naive individuals; 2) HIV-infected subjects, currently on ART, with >350 CD4+ T-cells/uL; 3) HIV-infected subjects, currently on ART, with <350 CD4+ T-cells/uL; 4) HIV negative healthy controls.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
HIV
  • Dietary Supplement: Prebiotics+Glutamine

    Prebiotics are nondigestible food ingredients, generally oligosaccharides, that modify intestinal microbiota balance by stimulating the growth of beneficial bacteria.

    Glutamine is a non-essential amino acid that can be metabolized by epithelial cells, enhancing barrier function.

  • Dietary Supplement: Placebo
    Maltodextrin, 20 g.
  • Experimental: Dietary Supplement: Prebiotics+Glutamine
    Intervention: Dietary Supplement: Prebiotics+Glutamine
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • After receiving information on the design and objectives of the study, the possible risks involved, and the fact that they can refuse to collaborate at any time, patients will give their informed consent to participate in the study and agree to provide material for the cellular and molecular studies.
  • Aged over 18 years.
  • Group 1: HIV+, Not receiving ART and no previous exposure to ART, at least 2 years since HIV diagnosis.
  • Group 2: HIV+, currently receiving ART for more than 2 years, HIV-1 RNA levels less than 40 copies/ml and more than 350 CD4+ T-cells/uL.
  • Group 3: HIV+, currently receiving ART for more than 2 years, HIV-1 RNA levels less than 40 copies/ml and less than 350 CD4+ T-cells/uL.
  • Group 4: HIV-, healthy controls.

Exclusion Criteria:

  • Major cardiovascular risk factors.
  • Concomitant acute diseases.
  • Gastrointestinal disorders.
  • Pregnancy.
  • Antibiotic exposure in the previous month.
  • Regular use of foods or supplements containing prebiotics or probiotics within the 2 weeks prior to initiation of the study.
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01838915
11/284
Yes
Sergio Serrano-Villar, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Not Provided
Not Provided
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
August 2013

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