NCT01838915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1 hiv

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
3.7 years until next milestone

Study Start

First participant enrolled

January 10, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

February 11, 2019

Status Verified

February 1, 2019

Enrollment Period

1.4 years

First QC Date

April 22, 2013

Last Update Submit

February 8, 2019

Conditions

HIV

Keywords

HIVimmunoactivationbacterial translocationprebioticsglutaminemicrobiota

Outcome Measures

Primary Outcomes (6)

  • Safety

    Adverse events monitoring during the intervention

    6 weeks

  • Changes in markers of bacterial translocation

    Soluble CD14 and increasing permeability binding protein.

    6 weeks

  • Changes in markers of immunoactivation

    Changes in percentages of CD4+ and CD8+ T-cells expressing CD25, HLADR, CD38.

    6 weeks

  • Changes in inflammatory markers

    Changes in interleukine-6 and high-sensitivity C Reactive Protein

    6 weeks

  • Changes in markers of endothelial dysfunction

    Changes in asymmetric dimethylarginine and flow-mediated dilation

    6 weeks

  • Changes in gut microbiota composition

    Changes in gut microbiota as determined by 454 pyrosequencing.

    6 weeks

Secondary Outcomes (4)

  • Changes in gut microbiota

    6 weeks

  • Disease progression in HIV-infected patients.

    6 weeks

  • Thymic function

    6 weeks

  • Gene expression in peripheral blood monocytic cells.

    6 weeks

Study Arms (2)

Dietary Supplement: Prebiotics+Glutamine

EXPERIMENTAL
Dietary Supplement: Prebiotics+Glutamine

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Prebiotics+GlutamineDIETARY_SUPPLEMENT

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: Prebiotics+Glutamine
PlaceboDIETARY_SUPPLEMENT

Maltodextrin, 20 g.

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Ramón y Cajal and Hospital Clínico San Carlos

Madrid, 28034, Spain

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-Doctoral Researcher

Study Record Dates

First Submitted

April 22, 2013

First Posted

April 24, 2013

Study Start

January 10, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

February 11, 2019

Record last verified: 2019-02

Locations

ES(1)