Clinical trial NCT02146027: Once a Day Use of Lactobacillus Casei Shirota on HIV-infected Patients Infected Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Keywords: HIV
Lactobacillus casei Shirota
NK cell
CD4
Lymphocyte
Cell activation
Antiretroviral therapy
Immune discordants
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Yakult Honsha Co., LTD
First posted: 2014-05-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Increase between baseline and after 6 weeks and 12 weeks in the absolute CD4+ T-cell count in active and placebo group.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in level of cell activation at week 12 count
timeFrame: baseline, week 12
measure: Change from baseline in level of cell activation at week 6
timeFrame: baseline, week 6
measure: Change from baseline in NK cytototoxic activity against K562 cells at week 6
timeFrame: baseline, week 6
measure: Change from baseline in NK cytototoxic activity against K562 cells at week 12
timeFrame: baseline, week 12
measure: Change from baseline in Intestinal symptoms score of the Inflammatory Bowel Disease Questionnaire (IBQD) at week 12
timeFrame: baseline, week 12
measure: Change from baseline in the intestinal microbiome in the participants taking Lactobacillus casei Shirota at week 12
timeFrame: baseline, week 12
measure: Number of participants with adverse events reasonable causal relationship with the study product in active and placebo groups
timeFrame: 12 weeks
measure: Change from baseline in plasma sCD4 levels at week 6
timeFrame: baseline, week 6
measure: Change from baseline in plasma sCD4 levels at week 12
timeFrame: baseline, week 12
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo - General Hospital
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Esper G Kallás, MD PhD
role: PRINCIPAL_INVESTIGATOR
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