Westlake Frequent-sampling Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Health Adults, Stability of Microbiome. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Gut microbiome [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Participants reside in Hangzhou
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Westlake University — Hangzhou
Identifiers
NCT: NCT07460687 · 20251208ZJS001