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.
Information provided by (Responsible Party):
JVillar, Parc de Salut Mar Identifier:
First received: July 22, 2013
Last updated: April 1, 2016
Last verified: April 2016

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Parc de Salut Mar:

Primary Outcome Measures:
  • To evaluate microbial translocation-Binding lipopolysaccharide Protein (LBP). [ Time Frame: From randomisation to 6 months. ] [ Designated as safety issue: Yes ]
  • To evaluate Gut microbiota composition. [ Time Frame: From randomisation to 6 months. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
  • Analyse parameters that determine the immune status: CD4 + lymphocyte count, CD 8 + and HIV viral load. [ Time Frame: From randomisation to 6 months. ] [ Designated as safety issue: Yes ]

Estimated 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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01908049

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: JVillar, MD, Parc de Salut Mar Identifier: NCT01908049     History of Changes
Other Study ID Numbers: PROB-VIH 
Study First Received: July 22, 2013
Last Updated: April 1, 2016
Health Authority: Spain: Ethics Committee

Keywords provided by Parc de Salut Mar:
Microbial translocation
microbiota composition

Additional relevant MeSH terms:
Infection processed this record on May 23, 2016