Westlake Gut Microbiome Study

Active, not recruiting

• Conditions: Gut Microbiota

• Registration Number: NCT04435548
• Lead Sponsor: Westlake University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-06-14
• Study First Submitted QC: 2020-06-14
• Study First Posted: 2020-06-17
• Study Start: 2021-09-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-05-02
• Primary Completion: 2025-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

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; -

Exclusion Criteria

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut microbiota	36 months	Fecal microbiome will be analyzed by 16S rRNA gene sequencing and metagenome sequencing.
Metabolomics of serum and gut microbiome	36 months	Metabolomics of serum and gut microbiome will be analyzed by liquid chromatograph-mass spectrometer (LC/MS)
Proteomic profiling of serum	36 months	Proteomic characterization of serum will be analyzed by liquid chromatograph-mass spectrometer (LC/MS)

Secondary Outcome Measures

Name	Time	Method
Biochemical examination of blood samples	36 months	Blood glucose, blood lipids, serum cytokines will be examined.
Body composition	36 months	Body composition will be analyzed using composition automatic analyzer at the time point of sample collection by compostion automatic analyzer.

Trial Locations

Locations (1)

Westlake University; 🇨🇳 Hangzhou, Zhejiang, China