Treatment With Probiotics (Saccharomyces Boulardii) and Its Role in Bacterial Translocation and Immune Reconstitution in HIV 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.
HIV -1 Infection
Dietary Supplement: Probiotic.
Dietary Supplement: Placebo
|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 HIV Infection.|
- 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).
- 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 ]
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||September 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
A probiotic (Saccharomyces boulardii) 2 caps/ 8h for 12 weeks.
|Dietary Supplement: Probiotic.|
Placebo Comparator: Placebo
No active substance is given.
|Dietary Supplement: Placebo|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01908049
|Contact: Villar Garcia Judit, Dr.||0034 firstname.lastname@example.org|
|Hospital del Mar||Recruiting|
|Barcelona, Spain, 08003|
|Contact: Villar Garcia Judit, Dr. 0034 635505451 email@example.com|
|Principal Investigator: Villar Garcia Judit, Dr.|