Westlake Gut Microbiome Study

Gut Microbiota Clinical Trial

Official title:

Multi-Omic Microbiome Study: Characterization of the Human Microbiota Among Chinese Population to Understant How the Microbiome Impacts Human Health.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04435548
• Other study ID #: 20190901ZJS0011
• Status: Active, not recruiting
• Start date: September 1, 2021
• Est. completion date: June 30, 2028

Study information

• Verified date: April 2022
• Source: Westlake University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4000
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 80 Years

Eligibility

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.

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Related Conditions & MeSH terms

• Gut Microbiota

Locations

Country	Name	City	State
China	Westlake University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Westlake University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiota	Fecal microbiome will be analyzed by 16S rRNA gene sequencing and metagenome sequencing.	36 months
Primary	Metabolomics of serum and gut microbiome	Metabolomics of serum and gut microbiome will be analyzed by liquid chromatograph-mass spectrometer (LC/MS)	36 months
Primary	Proteomic profiling of serum	Proteomic characterization of serum will be analyzed by liquid chromatograph-mass spectrometer (LC/MS)	36 months
Secondary	Body composition	Body composition will be analyzed using composition automatic analyzer at the time point of sample collection by compostion automatic analyzer.	36 months
Secondary	Biochemical examination of blood samples	Blood glucose, blood lipids, serum cytokines will be examined.	36 months