NCT04435548

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
25mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Sep 2021Jun 2028

First Submitted

Initial submission to the registry

June 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Expected
Last Updated

June 13, 2025

Status Verified

May 1, 2025

Enrollment Period

3.8 years

First QC Date

June 14, 2020

Last Update Submit

June 10, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Body composition

    36 months

  • Biochemical examination of blood samples

    36 months

Eligibility Criteria

Age1 Year - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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; -

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westlake University

Hangzhou, Zhejiang, 310024, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

venous blood, saliva, urine and feces.

Study Officials

  • Ju-Sheng Zheng, PhD

    Westlake University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2020

First Posted

June 17, 2020

Study Start

September 1, 2021

Primary Completion

June 30, 2025

Study Completion (Estimated)

June 30, 2028

Last Updated

June 13, 2025

Record last verified: 2025-05

Locations