Treatment With Probiotics (Saccharomyces Boulardii) and Its Role in Bacterial Translocation and Immune Reconstitution in VIH Infection.
- Conditions
- HIV -1 Infection
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Probiotic.
- Registration Number
- NCT01908049
- Lead Sponsor
- Parc de Salut Mar
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 44
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo No active substance is given. Probiotic Probiotic. A probiotic (Saccharomyces boulardii) 2 caps/ 8h for 12 weeks.
- Primary Outcome Measures
Name Time Method To evaluate microbial translocation-Binding lipopolysaccharide Protein (LBP). From randomisation to 6 months. To evaluate Gut microbiota composition. From randomisation to 6 months. Change in gut microbiota (454 pyrosequencing of fecal samples).
- Secondary Outcome Measures
Name Time Method 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. From randomisation to 6 months. Analyse parameters that determine the immune status: CD4 + lymphocyte count, CD 8 + and HIV viral load. From randomisation to 6 months.
Trial Locations
- Locations (1)
Hospital del Mar
🇪🇸Barcelona, Spain