NCT07460687

Brief Summary

This intensive longitudinal study investigates the day-to-day stability and natural fluctuations of the gut microbiome in healthy adults over a 15-day period. While the human gut microbiome is a complex ecosystem, its baseline stability in the absence of disease or medical intervention remains insufficiently characterized due to low sampling frequency in prior research. By recruiting healthy volunteers for continuous daily sampling, this study aims to map temporal community structures and evaluate the stability of core microbiota. Additionally, the research utilizes Continuous Glucose Monitoring (CGM) to explore the potential relationships between microbiome dynamics, daily dietary intake, and host glycemic stability.

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
17mo left

Started Apr 2026

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 Progress19%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

March 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

April 8, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 5, 2026

Last Update Submit

March 5, 2026

Conditions

Keywords

Microbiome

Outcome Measures

Primary Outcomes (1)

  • Gut microbiome

    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.

    1 year

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

March 5, 2026

First Posted

March 10, 2026

Study Start

April 8, 2026

Primary Completion (Estimated)

April 8, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations