Westlake Gut Microbiome Study

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Gut Microbiota

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 Type: Observational

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310024
      • Westlake University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All the participants should be Chinese residents, regardless of the ethics.

Description

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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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Westlake University
• Investigators: Principal Investigator: Ju-Sheng Zheng, PhD, Westlake University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: June 14, 2020
• First Submitted That Met QC Criteria: June 14, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 20190901ZJS0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No