Once a Day Use of Lactobacillus Casei Shirota on HIV-infected Patients Infected Patients

University of Sao Paulo General Hospital48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

HIV

Interventions

Fermented Milk Drink Yakult 40DIETARY_SUPPLEMENT

Lactobacillus casei Shirota, with 40 billion bacteria per 80 g (concentration of 5 x 10\^8 CFU/g). Intervention will be used for 12 weeks.

Fermented Milk Drink Yakult 40DIETARY_SUPPLEMENT

Ingredients: Skimmed milk and/or Reconstituted Skimmed Milk, Sugar, Glucose, Live Lactic Bacteria (Lactobacillus casei Shirota) 40 billions per 80 g - concentration of 5 x 108 CFU/g), Flavour. Gluten Free.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female HIV-1 infected patients aged between 18 and 60 years. * Patient on suppressive antiretroviral treatment with poor CD4+ T-cell recovery. * No change in antiretroviral therapy in the last six months or intended change in the next 12 weeks. * Availability for the study procedures during the study period. * Giving informed consent to participate in the study Exclusion Criteria: * Diagnosis of any concomitant infections or diseases that might affect immunity or natural history of HIV-1 infection including active Hepatitis B infection, Hepatitis C infection, diabetes mellitus, neoplasias and autoimmune diseases. * Use of treatments that might affect immunity in the last four weeks including immunomodulators, corticosteroids (only systemic use for two weeks or more), or antineoplasic agents. * History of intolerance or allergy to cow milk or any other component of the study product including lactose intolerance, casein allergy, etc. * Pregnancy, nursing mother or intention of became pregnant during the study period (only female participants). * Unable to safely store the study product at home in the conditions recommended by the manufacturer. * Any other condition that might interfere with the study procedure according to the investigators.

Locations (1)

University of Sao Paulo - General Hospital

São Paulo, Brazil

Outcomes

Primary Outcomes

Increase between baseline and after 6 weeks and 12 weeks in the absolute CD4+ T-cell count in active and placebo group.

Only differences greater than 50 T CD4+ cells/mm³ would be included in the analysis.

Time frame: 12 weeks

Secondary Outcomes

Change from baseline in level of cell activation at week 12 count

Cell activation will be accessed by flow cytometry assays in a FACSCanto flow cytometer, using the following monoclonal antibodies: CD3, CD4, CD8, CD38, CCR5, CD69, anti-HLA-DR+

Time frame: baseline, week 12

Change from baseline in level of cell activation at week 6

Cell activation will be accessed by flow cytometry assays in a FACSCanto flow cytometer, using the following monoclonal antibodies: CD3, CD4, CD8, CD38, CCR5, CD69, anti-HLA-DR+

Time frame: baseline, week 6

Change from baseline in NK cytototoxic activity against K562 cells at week 6

NK cell phenotyping and function will be assessed according to Long et al., were subpopulations of NK cells will be assessed by the expression of CD56, CD16 molecules in the CD3-CD14-CD20- population of mononuclear cells. Production of IFNgama and CD103a proteins will be evaluated by flow cytometry in K562 stimulated mononuclear cells

Time frame: baseline, week 6

Change from baseline in NK cytototoxic activity against K562 cells at week 12

Time frame: baseline, week 12

Data from ClinicalTrials.gov

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