Multi-Omic Microbiome Study: Characterization of the Human Microbiota Among Chinese Population to Understant How the Microbiome Impacts Human Health.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Gut microbiota
研究概览
简要总结
The Westlake Gut Microbiome study is a prospective cohort study. This project aims to characterize the gut microbiome among Chinese populations from different regions of China, and explore the relationships between gut microbiota and human health. Human fecal samples will be collected from the participants and muli-omics detection and analysis will be performed.
详细描述
In the first phase of the study (also a pilot study), the investigators will create a longitudinal datasets from a students-based cohort in Westlake University. Information about demography, life style, diet, medical history, physical activity will be recorded, clinical examinations such as blood glucose, body composition and electroencephalogram will be examined, and biological samples including blood, saliva, urine and feces, will be collected.
In the second phase, the investigators will expand to include eligible participants from at least 10 provinces of China, which are located at different regions. Similar to the procedures in phase 1 stage, information about demography, life style, diet, medical history, physical activity will be recorded, clinical examinations will be performed, and biological samples will be collected.
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
- 1 Year 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants or her/his legal guardian are able to report the antibiotics use during the past 3 months; Participants or her/his legal guardian are able to understand and respond to the online questionairs; Participants or her/his legal guardian are able and willing to collect the biological samples as instructed; Participants or her/his legal guardian are able and willing to provide written informed consent; -
排除标准
- •Those with serious fundamental diseases or infectious diseases; and those with other conditions that not suitable to participate in this study, as considered by the investigators.
结局指标
主要结局
Gut microbiota
时间窗: 36 months
Fecal microbiome will be analyzed by 16S rRNA gene sequencing and metagenome sequencing.
Metabolomics of serum and gut microbiome
时间窗: 36 months
Metabolomics of serum and gut microbiome will be analyzed by liquid chromatograph-mass spectrometer (LC/MS)
Proteomic profiling of serum
时间窗: 36 months
Proteomic characterization of serum will be analyzed by liquid chromatograph-mass spectrometer (LC/MS)
次要结局
- Biochemical examination of blood samples(36 months)
- Body composition(36 months)