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Treatment With Probiotics (Saccharomyces Boulardii) and Its Role in Bacterial Translocation and Immune Reconstitution in VIH Infection.

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01908049
First Posted: July 25, 2013
Last Update Posted: November 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
JVillar, Parc de Salut Mar
  Purpose

Objectives: MAIN: To evaluate the parameters of microbial translocation after treatment with probiotics (Saccharomyces boulardii) in HIV+ patients and its role on immune reconstitution and the changes in gut microbiota composition.

SECONDARY OBJECTIVES: 1) To analyze the progress of immune activity markers after the administration of probiotics. 2) To determine the improvement of CD4+ lymphocytes and HIV viral load in patients after taking probiotics.

Methods: Design: A prospective randomized open controlled double-blinded trial, to be performed at a tertiary care hospital in Barcelona. Subjects: Chronic HIV infected patients. Sample size: 44 cases. They´ll be divided in 2 groups: (1) Patients with CD4 +> 400 cells / ml and undetectable viral load for more than two years (22 cases) and (2) Patients with immunodiscordancy, defined as patients with CD4 + T cells lower than 350 cells / ml despite 4-7 years of effective antiretroviral therapy. (22 cases). Intervention: Patients were randomized in 2 subgroups: (A) they´ll receive daily oral supplementation with S. boulardii for 3 months and (B) they ´ll receive placebo. Variables: bacterial lipopolisaccharide levels measured by the Lipid-Binding protein (LBP), parameters of immune activation in plasma (soluble CD14, IFN-Υ, TNF-Alpha, IL (interleukine)-2, IL-5, IL-6, IL-12)and gut microbiota composition prior to the use of probiotics (baseline), at 3 and 6 months. Immunological and clinical data. Outcome measures: quantification of bacterial translocation levels, markers of activity and immune recovery. Analysis: Comparison of variables before and after the intervention. The analysis will be performed by biological and immunological effectiveness.


Condition Intervention Phase
HIV -1 Infection Dietary Supplement: Probiotic. Dietary Supplement: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment With Probiotics (Saccharomyces Boulardii) and Its Role in Bacterial Translocation and Immune Reconstitution in VIH Infection.

Resource links provided by NLM:


Further study details as provided by JVillar, Parc de Salut Mar:

Primary Outcome Measures:
  • To evaluate microbial translocation-Binding lipopolysaccharide Protein (LBP). [ Time Frame: From randomisation to 6 months. ]
  • To evaluate Gut microbiota composition. [ Time Frame: From randomisation to 6 months. ]
    Change in gut microbiota (454 pyrosequencing of fecal samples).


Secondary Outcome Measures:
  • To evaluate Markers of immune activity: soluble CD14 (sCD14), interferon gamma (IFN-Υ), tumor necrosis factor (TNF), IL-6, Reactive C protein, D -dimer, fibrinogen. [ Time Frame: From randomisation to 6 months. ]
  • Analyse parameters that determine the immune status: CD4 + lymphocyte count, CD 8 + and HIV viral load. [ Time Frame: From randomisation to 6 months. ]

Enrollment: 44
Study Start Date: August 2012
Estimated Study Completion Date: March 2017
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic
A probiotic (Saccharomyces boulardii) 2 caps/ 8h for 12 weeks.
Dietary Supplement: Probiotic.
Placebo Comparator: Placebo
No active substance is given.
Dietary Supplement: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with chronic HIV infection and viral load undetectable > two years with stable ART CD4> 400 cells / ml.
  • Patients with chronic HIV infection and viral load undetectable> two years with stable ART CD4 <350 cells / ml.
  • Inform consent signed.
  • Aged between 18- No limit.

Exclusion Criteria:

  • Patients who receive or have received in the past 6 months food supplements containing probiotics.
  • Patients who have received antibiotic treatment in the last two months
  • Patients who are poor presupposes adherence to dietary supplements.
  • Patients who have changed the TAR in the last three months.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908049


Locations
Spain
Hospital del Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JVillar, MD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01908049     History of Changes
Other Study ID Numbers: PROB-VIH
First Submitted: July 22, 2013
First Posted: July 25, 2013
Last Update Posted: November 15, 2016
Last Verified: November 2016

Keywords provided by JVillar, Parc de Salut Mar:
Probiotic
HIV
Microbial translocation
inflammation
microbiota composition

Additional relevant MeSH terms:
Infection
Communicable Diseases