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Completed

NCT Number: NCT02146027

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

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.

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Key information

Conditions

HIV

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Sao Paulo - General Hospital

São Paulo, 01246-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fermented Milk Drink Yakult 40

Dietary 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.

Other names: Yakult, Live Lactic Bacteria (Lactobacillus casei Shirota)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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+

  2. 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+

  3. 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

  4. 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

  5. Change from baseline in Intestinal symptoms score of the Inflammatory Bowel Disease Questionnaire (IBQD) at week 12

    Time frame: baseline, week 12

  6. Change from baseline in the intestinal microbiome in the participants taking Lactobacillus casei Shirota at week 12

    Time frame: baseline, week 12

  7. Number of participants with adverse events reasonable causal relationship with the study product in active and placebo groups

    Time frame: 12 weeks

  8. Change from baseline in plasma sCD4 levels at week 6

    Time frame: baseline, week 6

    CD14 levels will be measured using commercially available kits

  9. Change from baseline in plasma sCD4 levels at week 12

    Time frame: baseline, week 12

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Yakult Honsha Co., LTD

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 23, 2014
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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