NCT07606885

Brief Summary

This observational follow-up study extends a previously completed 15-day intensive longitudinal study (WeF) of the gut microbiome in healthy adults. The objective of WeF2 is to characterize the long-term stability and dynamics of the gut and oral microbiota in the same cohort across multiple timescales, and to determine whether the day-to-day variability patterns observed at baseline persist over months and years. Participants who completed the WeF baseline protocol will be invited to attend periodic follow-up visits for low-frequency biospecimen collection and to repeat the original 15-day high-frequency sampling protocol at planned intervals, beginning approximately six months after the WeF baseline and continuing at extended intervals thereafter. By combining sparse routine sampling with recurring high-density sampling windows, the study aims to distinguish the stable core microbiome from transient and seasonal fluctuations, to track gradual community shifts under free-living conditions, and to further explore relationships among microbiome dynamics, dietary intake, and host glycemic regulation over an extended observation period.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
54mo left

Started May 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress5%
May 2026Dec 2030

Study Start

First participant enrolled

May 8, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2027

Expected
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

May 26, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

May 19, 2026

Last Update Submit

May 19, 2026

Conditions

Keywords

Microbiome

Outcome Measures

Primary Outcomes (1)

  • Gut microbiome

    Description: Using qPCR, metagenomics, metabolomics, proteomics, and culturomics, we quantified the composition and absolute abundance of the gut microbiota and characterized its short-term and long-term dynamics.

    3 years

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy young adults residing in Hangzhou

You may qualify if:

  • Participants reside in Hangzhou

You may not qualify if:

  • Refusing or unable to give informed consent
  • Participants with chronic gastrointestinal diseases and take daily relevant medications
  • Participants with metabolic diseases including diabetes, hypertension and cardiovascular diseases (CVD)
  • Participants with craniocerebral trauma, cancer, liver disease, kidney disease, or other critical illness, or history of operation or medication
  • Participants with bulimia nervosa, post-traumatic stress disorder (PTSD), chronic anxiety and depression or other critical neuronal disorder or history of relevant medication
  • Being or to be pregnant or lactating.
  • Participants with history of alcohol or drug addiction, or smoke above 15 cigarettes per day
  • Concurrently participating other clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westlake University

Hangzhou, Zhejiang, 310024, China

RECRUITING

Study Officials

  • Ju-Sheng Zheng, PhD

    Westlake University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiang-Hua Zhang, Bachelor

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 19, 2026

First Posted

May 26, 2026

Study Start

May 8, 2026

Primary Completion (Estimated)

May 8, 2027

Study Completion (Estimated)

December 31, 2030

Last Updated

May 26, 2026

Record last verified: 2026-04

Locations