Westlake Frequent-sampling Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Gut microbiome
研究概览
简要总结
This intensive longitudinal study investigates the day-to-day stability and natural fluctuations of the gut microbiome in healthy adults over a 15-day period. While the human gut microbiome is a complex ecosystem, its baseline stability in the absence of disease or medical intervention remains insufficiently characterized due to low sampling frequency in prior research. By recruiting healthy volunteers for continuous daily sampling, this study aims to map temporal community structures and evaluate the stability of core microbiota. Additionally, the research utilizes Continuous Glucose Monitoring (CGM) to explore the potential relationships between microbiome dynamics, daily dietary intake, and host glycemic stability.
详细描述
This non-interventional, observational study utilizes high-frequency sampling to capture biological and physiological dynamics under free-living conditions. Participants undergo a 15-day monitoring period involving the daily collection of saliva (5 mL) and stool (40 g) samples for microbial sequencing and functional evaluation. Simultaneously, participants provide samples of every meal consumed to allow for DNA sequencing of food sources, providing an objective record of dietary intake to correlate with microbiome shifts. Throughout the study, volunteers wear a CGM device to continuously record blood glucose data, which is integrated with microbial and nutritional datasets to differentiate intra-individual fluctuations from inter-individual differences. To ensure data integrity and participant safety, the study is overseen by a Data and Safety Monitoring Board and adheres to ethical standards approved by the Westlake University Ethics Committee.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants reside in Hangzhou
排除标准
- •Refusing or unable to give informed consent
- •Participants with chronic gastrointestinal diseases and take daily relevant medications
- •Participants with metabolic diseases including diabetes, hypertension and cardiovascular diseases (CVD)
- •Participants with craniocerebral trauma, cancer, liver disease, kidney disease, or other critical illness, or history of operation or medication
- •Participants with bulimia nervosa, post-traumatic stress disorder (PTSD), chronic anxiety and depression or other critical neuronal disorder or history of relevant medication
- •Being or to be pregnant or lactating.
- •Participants with history of alcohol or drug addiction, or smoke above 15 cigarettes per day
- •Concurrently participating other clinical trials.
结局指标
主要结局
Gut microbiome
时间窗: 1 year
Using qPCR, metagenomics, metabolomics, proteomics, and culturomics, we quantified the composition and absolute abundance of the gut microbiota and characterized its short-term and long-term dynamics.
次要结局
未报告次要终点