Use of Probiotic to Modulate Vaginal Microflora and General Women's Health
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- differences in immunity of women
研究概览
简要总结
The purpose of this study is to evaluate the effects of oral administration of probiotic at 9 log colony forming unit (CFU)/day on vaginal microbiota profiles compared to placebo via the use of vaginal self-swab microbiota profiling.
详细描述
- To evaluate differences in general women's health of women on probiotic and placebo via the use of questionnaire.
- To evaluate differences in immunity of women on probiotic and placebo via blood immunity profiling.
- To evaluate differences in gut microbiota profiles of women on probiotic and placebo via blood fecal microbiota profiling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The randomization will be performed by the study statistician, who had no contact with the participants. The allocation sequence will not available to any member of the research team until databases had been completed and locked. Since this is a double-blinded study, both the research team and subject will not know in which group the subject is assigned to.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Generally, healthy women aged 18-
- •Currently free from urogenital infections such as urinary tract infection (UTI), bacterial vaginosis (BV), or yeast vaginitis.
- •Willing to commit throughout the experiment.
排除标准
- •Pregnant.
- •On vaginal suppository treatments within 4-weeks prior to entering the study.
- •On oral medication for vaginal illnesses or any vaginal therapy such as hormones and estrogen within 4-weeks prior to entering the study.
- •On long term medication (> 6 months) for any illnesses.
- •Have used vaginal estrogen cream, ring or tablet within 4-weeks prior to entering the study.
- •Have used vaginal moisturizers, lubricants or homeopathic preparations within 4-weeks prior to entering the study.
- •Have used spermicide agent within 4-weeks prior to entering the study.
- •Pelvic or any gynecologic surgery 6-months prior to entering the study.
结局指标
主要结局
differences in immunity of women
时间窗: 12 weeks
To evaluate differences in immunity of women on probiotic and placebo in terms of blood immunity profiling via measuring concentrations of cytokines such as interleukin (IL)-1b using commercially available ELISA kit.
differences in gut microbiota profiles of women
时间窗: 12 weeks
To evaluate differences in gut microbiota profiles of women on probiotic and placebo via microbiota profiling using DNA of fecal samples amplified for bacterial 16S rRNA and analyzed for high-throughput community sequencing.
differences in general women's health
时间窗: 12 weeks
To evaluate differences in general women's health of women on probiotic and placebo via the use of the Women's Health Questionnaire (WHQ) questionnaire containing 37-items covering aspects of anxiety and depression, memory, sleep and sexual issues, on a 4-point Likert scale including some items with reverse scoring, with higher scores indicating poorer health status.
次要结局
未报告次要终点
研究者
Min-Tze LIONG
Professor
Universiti Sains Malaysia