HIV Clinical Trial
Official title:
Immunological Effects of Continuous, Once a Day Use of Lactobacillus Casei Shirota on HIV-infected Patients on Suppressive Antiretroviral Treatment With Poor CD4+ T-cell Recovery
In this study, HIV-infected patients with poor recovery of CD4+ T cells and successful viral
control after treatment with antiretroviral therapy will be enrolled to receive once a day
Lactobcillus casei Shirota or placebo in a double-blind, randomized fashion. Immune
parameters will be monitored for 12 weeks in both arms.
The main outcome is CD4+ T cell recovery. Secondary outcomes will include NK cells and T
cells immune parameters.
In this study, HIV-infected patients with poor recovery of CD4+ T cells and successful viral
control after treatment with antiretroviral therapy will be enrolled to receive once a day
Lactobcillus casei Shirota or placebo in a double-blind, randomized fashion.
The main objective is to investigate whether the continuous, once a day, 12-weeks use of
Yakult product containing Lactobacillus casei Shirota could affect immunological parameters
in HIV-infected patients on suppressive antiretroviral treatment with poor CD4+ T cell
recovery. A total of 48 volunteers will be followed for 12 week after initiation of daily
use of Lactobcillus casei Shirota or placebo, randomized in a 1:1 ratio.
We hypothesize that use of the Yakult product containing Lactobacillus casei Shirota after
12 weeks of continuous use will increase the level of CD4+ T-cells, at least, 50 cells/mm³.
We also propose to investigate several markers of immune response, including T cellular
activation and NK cells function, and changes in the intestinal microbiota.
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