Health AdultsWeFNCT07460687
Westlake Frequent-sampling Cohort
An observational study of Health Adults and Stability of Microbiome, run by Westlake University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Adults, Stability of Microbiome
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 15 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy young adults residing in Hangzhou
Who may be able to join
- Participants reside in Hangzhou
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Health Adults, Stability of Microbiome
- Keywords
- Microbiome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment
Secondary outcomes (1)
Continuous blood glucose change over 2 weeks
Glucose levels are assessed by continuous glucose monitoring over 2 weeks.
Measured: Two weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Jan 2026
- Primary completion15 Feb 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westlake University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ju-Sheng Zheng, PhD, Principal investigator, Westlake University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460687
- Sponsor's protocol ID
- 20251208ZJS001
- Acronym
- WeF
- Status last verified
- Aug 2026
- First submitted
- 5 Mar 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Westlake Frequent-sampling Cohort
- ClinicalTrials.gov ID
- NCT07460687
- Acronym / sponsor ID
- WeF / 20251208ZJS001
- Conditions
- Health Adults, Stability of Microbiome
- Keywords
- Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Westlake UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy young adults residing in Hangzhou
Key inclusion criteria (1 listed)
- Participants reside in Hangzhou
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gut microbiome
Time frame: At enrollment
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 secondary outcome
Continuous blood glucose change over 2 weeks
Time frame: Two weeks after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
Related trials for Health Adults
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruiting
ACUTE EFFECTS OF HIGH-INTENSITY LASER THERAPY ON PAIN, MUSCLE STIFFNESS, AND GRIP STRENGTH IN HEALTHY ADULTS
Exercise-Induced Muscle Fatigue, Fatigue Recovery
Not yet recruiting
Examining the Health Impact of and Promoting Sitting Light Volleyball in the Greater Bay Area
Physial Disabilities
Not yet recruiting
Evaluation of the Axomove Therapy Medical Device to Facilitate Adapted Physical Activity for Patients With Obesity
Obese Adults
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju-Sheng Zheng, PhD principal investigator
Westlake University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Adults and Stability of Microbiome, run by Westlake University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.