This trial is active, not recruiting.

Condition hiv -1 infection
Treatments probiotic., placebo
Phase phase 2
Sponsor Parc de Salut Mar
Start date August 2012
End date July 2013
Trial size 44 participants
Trial identifier NCT01908049, PROB-VIH


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
A probiotic (Saccharomyces boulardii) 2 caps/ 8h for 12 weeks.
(Placebo Comparator)
No active substance is given.

Primary Outcomes

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.

Secondary Outcomes

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.

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Treatment With Probiotics (Saccharomyces Boulardii) and Its Role in Bacterial Translocation and Immune Reconstitution in VIH Infection.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Parc de Salut Mar.