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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Increase between baseline and after 6 weeks and 12 weeks in the absolute CD4+ T-cell count in active and placebo group.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Increase between baseline and after 6 weeks and 12 weeks in the absolute CD4+ T-cell count in active and placebo group.
时间窗: 12 weeks
Only differences greater than 50 T CD4+ cells/mm³ would be included in the analysis.
次要结局
- Change from baseline in level of cell activation at week 6(baseline, week 6)
- Change from baseline in Intestinal symptoms score of the Inflammatory Bowel Disease Questionnaire (IBQD) at week 12(baseline, week 12)
- Change from baseline in the intestinal microbiome in the participants taking Lactobacillus casei Shirota at week 12(baseline, week 12)
- Change from baseline in level of cell activation at week 12 count(baseline, week 12)
- Change from baseline in NK cytototoxic activity against K562 cells at week 6(baseline, week 6)
- Change from baseline in NK cytototoxic activity against K562 cells at week 12(baseline, week 12)
- Number of participants with adverse events reasonable causal relationship with the study product in active and placebo groups(12 weeks)
- Change from baseline in plasma sCD4 levels at week 6(baseline, week 6)
- Change from baseline in plasma sCD4 levels at week 12(baseline, week 12)
研究者
Esper Georges Kallás
MD PhD
University of Sao Paulo General Hospital