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

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. Identifier: NCT01908049
Recruitment Status : Active, not recruiting
First Posted : July 25, 2013
Last Update Posted : November 15, 2016
Information provided by (Responsible Party):
JVillar, Parc de Salut Mar

July 22, 2013
July 25, 2013
November 15, 2016
August 2012
July 2013   (Final data collection date for primary outcome measure)
  • 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).
Same as current
Complete list of historical versions of study NCT01908049 on Archive Site
  • 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. ]
Same as current
Not Provided
Not Provided
Treatment With Probiotics (Saccharomyces Boulardii) and Its Role in Bacterial Translocation and Immune Reconstitution in VIH Infection.
Treatment With Probiotics (Saccharomyces Boulardii) and Its Role in Bacterial Translocation and Immune Reconstitution in VIH Infection.

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.

Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV -1 Infection
  • Dietary Supplement: Probiotic.
  • Dietary Supplement: Placebo
  • Experimental: Probiotic
    A probiotic (Saccharomyces boulardii) 2 caps/ 8h for 12 weeks.
    Intervention: Dietary Supplement: Probiotic.
  • Placebo Comparator: Placebo
    No active substance is given.
    Intervention: Dietary Supplement: Placebo
Villar-García J, Hernández JJ, Güerri-Fernández R, González A, Lerma E, Guelar A, Saenz D, Sorlí L, Montero M, Horcajada JP, Knobel Freud H. Effect of probiotics (Saccharomyces boulardii) on microbial translocation and inflammation in HIV-treated patients: a double-blind, randomized, placebo-controlled trial. J Acquir Immune Defic Syndr. 2015 Mar 1;68(3):256-63. doi: 10.1097/QAI.0000000000000468.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
March 2017
July 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
JVillar, Parc de Salut Mar
Parc de Salut Mar
Not Provided
Not Provided
Parc de Salut Mar
November 2016

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