CClinicalTrials.gg
CompletedNCT07460687WeFUpdated Sep 29, 2026

Westlake Frequent-sampling Cohort

An observational study in Health Adults and Stability of Microbiome, sponsored by Westlake University. Completed at 1 site in China. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Westlake University · Observational

Updated Sep 29, 2026Now CompletedStart date moved+4 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the detailed description

This non-interventional, observational study utilizes high-frequency sampling to capture biological and physiological dynamics under free-living conditions. Participants undergo a 15-day monitoring period involving the daily collection of saliva (5 mL) and stool (40 g) samples for microbial sequencing and functional evaluation. Simultaneously, participants provide samples of every meal consumed to allow for DNA sequencing of food sources, providing an objective record of dietary intake to correlate with microbiome shifts. Throughout the study, volunteers wear a CGM device to continuously record blood glucose data, which is integrated with microbial and nutritional datasets to differentiate intra-individual fluctuations from inter-individual differences. To ensure data integrity and participant safety, the study is overseen by a Data and Safety Monitoring Board and adheres to ethical standards approved by the Westlake University Ethics Committee.

02

Conditions studied

  • Health Adults
  • Stability of Microbiome

Keywords

  • Microbiome
03

In context

Lead sponsor

Westlake University is the lead sponsor of 28 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy young adults residing in Hangzhou

Inclusion criteria

  • Participants reside in Hangzhou

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No
06

What researchers measure

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.

    Time frame: At enrollment

Secondary outcomes

  1. Continuous blood glucose change over 2 weeks

    Glucose levels are assessed by continuous glucose monitoring over 2 weeks.

    Time frame: Two weeks after enrollment

07

Study locations

1 site
  • Westlake University
    Hangzhou, Zhejiang 310024, China
08

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Sep 29, 2026
Start date
Apr 8, 2026→Jan 1, 2026 (actual)
Sep 29, 2026
Primary completion
Apr 8, 2027→Feb 15, 2026 (actual)
Sep 29, 2026
Study completion
Dec 31, 2027→Feb 15, 2026 (actual)
Sep 29, 2026
Also revised
primary outcomes
Show all 1 update
  1. Sep 29, 2026
    Recruiting→Completed
    Start date Apr 8, 2026→Jan 1, 2026 (now actual)
    Primary completion Apr 8, 2027→Feb 15, 2026 (now actual)
    Study completion Dec 31, 2027→Feb 15, 2026 (now actual)
    Primary outcomes Revised (1 change)
    + 4 other changes: verification date, secondary outcomes, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07460687
Lead sponsor
Westlake University
Responsible party
Sponsor
First posted
Mar 10, 2026
Start date
Jan 1, 2026
Primary completion
Feb 15, 2026
Completion
Feb 15, 2026
Last update
Sep 29, 2026

Study contacts

Ju-Sheng Zheng, PhD
principal investigator · Westlake University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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