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

Primary Purpose

HIV

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Prebiotics+Glutamine
Placebo
Sponsored by
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring HIV, immunoactivation, bacterial translocation, prebiotics, glutamine, microbiota

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital Ramón y Cajal and Hospital Clínico San Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dietary Supplement: Prebiotics+Glutamine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Safety
Adverse events monitoring during the intervention
Changes in markers of bacterial translocation
Soluble CD14 and increasing permeability binding protein.
Changes in markers of immunoactivation
Changes in percentages of CD4+ and CD8+ T-cells expressing CD25, HLADR, CD38.
Changes in inflammatory markers
Changes in interleukine-6 and high-sensitivity C Reactive Protein
Changes in markers of endothelial dysfunction
Changes in asymmetric dimethylarginine and flow-mediated dilation
Changes in gut microbiota composition
Changes in gut microbiota as determined by 454 pyrosequencing.

Secondary Outcome Measures

Changes in gut microbiota
Changes in gut microbiota by 454 pyrosequencing of fecal samples.
Disease progression in HIV-infected patients.
Levels of CD4+ T-cell and HIV-1 RNA copies/mL
Thymic function
Gene expression in peripheral blood monocytic cells.

Full Information

First Posted
April 22, 2013
Last Updated
February 8, 2019
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
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1. Study Identification

Unique Protocol Identification Number
NCT01838915
Brief Title
Randomized Placebo-controlled Pilot Trial of Prebiotics+Glutamine in HIV Infection
Acronym
MicroVIH
Official Title
Gut Microbiota, Bacterial Translocation, Immune Activation and Endothelial Dysfunction in HIV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
HIV, immunoactivation, bacterial translocation, prebiotics, glutamine, microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary Supplement: Prebiotics+Glutamine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Prebiotics+Glutamine
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Maltodextrin, 20 g.
Primary Outcome Measure Information:
Title
Safety
Description
Adverse events monitoring during the intervention
Time Frame
6 weeks
Title
Changes in markers of bacterial translocation
Description
Soluble CD14 and increasing permeability binding protein.
Time Frame
6 weeks
Title
Changes in markers of immunoactivation
Description
Changes in percentages of CD4+ and CD8+ T-cells expressing CD25, HLADR, CD38.
Time Frame
6 weeks
Title
Changes in inflammatory markers
Description
Changes in interleukine-6 and high-sensitivity C Reactive Protein
Time Frame
6 weeks
Title
Changes in markers of endothelial dysfunction
Description
Changes in asymmetric dimethylarginine and flow-mediated dilation
Time Frame
6 weeks
Title
Changes in gut microbiota composition
Description
Changes in gut microbiota as determined by 454 pyrosequencing.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Changes in gut microbiota
Description
Changes in gut microbiota by 454 pyrosequencing of fecal samples.
Time Frame
6 weeks
Title
Disease progression in HIV-infected patients.
Description
Levels of CD4+ T-cell and HIV-1 RNA copies/mL
Time Frame
6 weeks
Title
Thymic function
Time Frame
6 weeks
Title
Gene expression in peripheral blood monocytic cells.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Ramón y Cajal and Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28034
Country
Spain

12. IPD Sharing Statement

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

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