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

May 3, 2017 updated by: Esper Georges Kallás, University of Sao Paulo General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 01246-903
        • University of São Paulo - General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fermented Milk Drink Yakult 40

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.
Dietary supplement: Fermented Milk Drink Yakult 40
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.
Other Names:
  • Yakult
  • Live Lactic Bacteria (Lactobacillus casei Shirota)
Dietary supplement: Fermented Milk Drink Yakult 40
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.
Other Names:
  • Yakult
  • Live Lactic Bacteria (Lactobacillus casei Shirota)
Placebo Comparator: Placebo

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
Dietary supplement: Fermented Milk Drink Yakult 40
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.
Other Names:
  • Yakult
  • Live Lactic Bacteria (Lactobacillus casei Shirota)
Dietary supplement: Fermented Milk Drink Yakult 40
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.
Other Names:
  • Yakult
  • Live Lactic Bacteria (Lactobacillus casei Shirota)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase between baseline and after 6 weeks and 12 weeks in the absolute CD4+ T-cell count in active and placebo group.
Time Frame: 12 weeks
Only differences greater than 50 T CD4+ cells/mm³ would be included in the analysis.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in level of cell activation at week 12 count
Time Frame: baseline, week 12
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+
baseline, week 12
Change from baseline in level of cell activation at week 6
Time Frame: baseline, 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+
baseline, week 6
Change from baseline in NK cytototoxic activity against K562 cells at week 6
Time Frame: baseline, 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
baseline, week 6
Change from baseline in NK cytototoxic activity against K562 cells at week 12
Time Frame: baseline, week 12
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
baseline, week 12
Change from baseline in Intestinal symptoms score of the Inflammatory Bowel Disease Questionnaire (IBQD) at week 12
Time Frame: baseline, week 12
baseline, week 12
Change from baseline in the intestinal microbiome in the participants taking Lactobacillus casei Shirota at week 12
Time Frame: baseline, week 12
baseline, week 12
Number of participants with adverse events reasonable causal relationship with the study product in active and placebo groups
Time Frame: 12 weeks
12 weeks
Change from baseline in plasma sCD4 levels at week 6
Time Frame: baseline, week 6
CD14 levels will be measured using commercially available kits
baseline, week 6
Change from baseline in plasma sCD4 levels at week 12
Time Frame: baseline, week 12
baseline, week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Yakult Honsha Co., LTD

Investigators

  • Principal Investigator: Esper G Kallás, MD PhD, University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

May 20, 2014

First Posted (Estimate)

May 23, 2014

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • YAKULT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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