Longitudinal Analysis of the Vaginal Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Identification of vaginal microbial functions
研究概览
简要总结
This is a longitudinal, observational study with the goal of understanding vaginal microbiome changes both within a single day and across a menstrual cycle. The study will be composed of at least 10 women that have regular menstrual cycles and are 18 years of age or older. This study is direct to participant and will NOT utilize clinical sites.
详细描述
Eligible women will be recruited into the study. They will be consented and asked to complete a health questionnaire. On six separate days during two menstrual cycles, they will be asked to collect vaginal swab samples (total of 12). For each sample collection, they will answer the sample collection questionnaire. Samples will be returned to Viome labs for analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Biological sex is female
- •Willing to collect own vaginal samples
- •Willing to answer health questions
- •Experience menstrual cycles regularly (a monthly cycle)
排除标准
- •Antibiotic use in the past 3 months
结局指标
主要结局
Identification of vaginal microbial functions
时间窗: 1 year
A vaginal metatranscriptomic test will be used to analyze the vaginal microbiome functions
Identification of vaginal microbial taxonomy
时间窗: 1 year
A vaginal metatranscriptomic test will be used to analyze the vaginal microbiome taxonomy
次要结局
未报告次要终点