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

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 2

Conditions: HIV

Treatments: Dietary Supplement: Fermented Milk Drink Yakult 40

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02146027

YAKULT

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

Fermented Milk Drink Yakult 40

Experimental group

Description:

Lactobacillus casei Shirota, contained in the Fermented Milk Drink Yakult 40 Once daily 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.

Treatment:

Dietary Supplement: Fermented Milk Drink Yakult 40

Dietary Supplement: Fermented Milk Drink Yakult 40

Placebo

Placebo Comparator group

Description:

The placebo would be an analogous product without Live Lactic Bacteria (Lactobacillus casei Shirota) presented in the same bottle and similar flavor. Both, Yakult 40 and placebo should be stored refrigerated between 1° and 10°C and

Treatment:

Dietary Supplement: Fermented Milk Drink Yakult 40

Dietary Supplement: Fermented Milk Drink Yakult 40