HIV -1 Infection
Conditions
Keywords
Probiotic, HIV, Microbial translocation, inflammation, microbiota composition
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.
Interventions
DIETARY_SUPPLEMENTProbiotic.
DIETARY_SUPPLEMENTPlacebo
Sponsors
Parc de Salut Mar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. |
Countries
Spain
Outcome results
None listed