Recruitment

Recruitment Status
Completed

Inclusion Criteria

Giving informed consent to participate in the study
Patient on suppressive antiretroviral treatment with poor CD4+ T-cell recovery.
Male or female HIV-1 infected patients aged between 18 and 60 years.
...
Giving informed consent to participate in the study
Patient on suppressive antiretroviral treatment with poor CD4+ T-cell recovery.
Male or female HIV-1 infected patients aged between 18 and 60 years.
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.

Exclusion Criteria

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.
Unable to safely store the study product at home in the conditions recommended by the manufacturer.
...
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.
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.
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.
Pregnancy, nursing mother or intention of became pregnant during the study period (only female participants).

Summary

Conditions
HIV
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

Description

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 wh...

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.

Inclusion Criteria

Giving informed consent to participate in the study
Patient on suppressive antiretroviral treatment with poor CD4+ T-cell recovery.
Male or female HIV-1 infected patients aged between 18 and 60 years.
...
Giving informed consent to participate in the study
Patient on suppressive antiretroviral treatment with poor CD4+ T-cell recovery.
Male or female HIV-1 infected patients aged between 18 and 60 years.
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.

Exclusion Criteria

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.
Unable to safely store the study product at home in the conditions recommended by the manufacturer.
...
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.
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.
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.
Pregnancy, nursing mother or intention of became pregnant during the study period (only female participants).

Tracking Information

NCT #
NCT02146027
Collaborators
Yakult Honsha Co., LTD
Investigators
  • Principal Investigator: Esper G Kallás, MD PhD University of Sao Paulo General Hospital
  • Esper G Kallás, MD PhD University of Sao Paulo General Hospital
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