Gut MicrobiotaNCT04435548
Westlake Gut Microbiome Study
An observational study of Gut Microbiota, run by Westlake University at 1 site in China.
Trial summary
The Westlake Gut Microbiome study is a prospective cohort study. This project aims to characterize the gut microbiome among Chinese populations from different regions of China, and explore the relationships between gut microbiota and human health. Read more about this study
- Who is it for?
- Ages 1 year to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 30 Jun 2028
- 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 1 year to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All the participants should be Chinese residents, regardless of the ethics.
Who may be able to join
- Participants or her/his legal guardian are able to report the antibiotics use during the past 3 months; Participants or her/his legal guardian are able to understand and respond to the online questionairs; Participants or her/his legal guardian are able and willing to collect the biological samples as instructed; Participants or her/his legal guardian are able and willing to provide written informed consent; -
Who cannot join
- Those with serious fundamental diseases or infectious diseases; and those with other conditions that not suitable to participate in this study, as considered by the investigators.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Omic Microbiome Study: Characterization of the Human Microbiota Among Chinese Population to Understant How the Microbiome Impacts Human Health.
The Westlake Gut Microbiome study is a prospective cohort study. This project aims to characterize the gut microbiome among Chinese populations from different regions of China, and explore the relationships between gut microbiota and human health. Human fecal samples will be collected from the participants and muli-omics detection and analysis will be performed.
Read the detailed description
In the first phase of the study (also a pilot study), the investigators will create a longitudinal datasets from a students-based cohort in Westlake University. Information about demography, life style, diet, medical history, physical activity will be recorded, clinical examinations such as blood glucose, body composition and electroencephalogram will be examined, and biological samples including blood, saliva, urine and feces, will be collected.
In the second phase, the investigators will expand to include eligible participants from at least 10 provinces of China, which are located at different regions. Similar to the procedures in phase 1 stage, information about demography, life style, diet, medical history, physical activity will be recorded, clinical examinations will be performed, and biological samples will be collected.
- Conditions
- Gut Microbiota
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota
Fecal microbiome will be analyzed by 16S rRNA gene sequencing and metagenome sequencing.
Measured: 36 months
Metabolomics of serum and gut microbiome
Metabolomics of serum and gut microbiome will be analyzed by liquid chromatograph-mass spectrometer (LC/MS)
Measured: 36 months
Proteomic profiling of serum
Proteomic characterization of serum will be analyzed by liquid chromatograph-mass spectrometer (LC/MS)
Measured: 36 months
Secondary outcomes (2)
Body composition
Body composition will be analyzed using composition automatic analyzer at the time point of sample collection by compostion automatic analyzer.
Measured: 36 months
Biochemical examination of blood samples
Blood glucose, blood lipids, serum cytokines will be examined.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start1 Sep 2021
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2028 (estimated)
Why it stopped: Owing to the impact of COVID-19, the study had to be withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies 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
- 0 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
- NCT04435548
- Sponsor's protocol ID
- 20190901ZJS0011
- Status last verified
- May 2025
- First submitted
- 14 Jun 2020
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Omic Microbiome Study: Characterization of the Human Microbiota Among Chinese Population to Understant How the Microbiome Impacts Human Health.
- ClinicalTrials.gov ID
- NCT04435548
- Acronym / sponsor ID
- 20190901ZJS0011
- Conditions
- Gut Microbiota
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Owing to the impact of COVID-19, the study had to be withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Westlake UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 17 Jun 2020 (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.
The Westlake Gut Microbiome study is a prospective cohort study. This project aims to characterize the gut microbiome among Chinese populations from different regions of China, and explore the relationships between gut microbiota and human health. Human fecal samples will be collected from the participants and muli-omics detection and analysis will be performed.
Detailed description
In the first phase of the study (also a pilot study), the investigators will create a longitudinal datasets from a students-based cohort in Westlake University. Information about demography, life style, diet, medical history, physical activity will be recorded, clinical examinations such as blood glucose, body composition and electroencephalogram will be examined, and biological samples including blood, saliva, urine and feces, will be collected.
In the second phase, the investigators will expand to include eligible participants from at least 10 provinces of China, which are located at different regions. Similar to the procedures in phase 1 stage, information about demography, life style, diet, medical history, physical activity will be recorded, clinical examinations will be performed, and biological samples will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the participants should be Chinese residents, regardless of the ethics.
Key inclusion criteria (1 listed)
- Participants or her/his legal guardian are able to report the antibiotics use during the past 3 months; Participants or her/his legal guardian are able to understand and respond to the online questionairs; Participants or her/his legal guardian are able and willing to collect the biological samples as instructed; Participants or her/his legal guardian are able and willing to provide written informed consent; -
Key exclusion criteria (2 listed)
- Those with serious fundamental diseases or infectious diseases; and those with other conditions that not suitable to participate in this study, as considered by the investigators.
- -
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 microbiota
Time frame: 36 months
Fecal microbiome will be analyzed by 16S rRNA gene sequencing and metagenome sequencing.
Metabolomics of serum and gut microbiome
Time frame: 36 months
Metabolomics of serum and gut microbiome will be analyzed by liquid chromatograph-mass spectrometer (LC/MS)
Proteomic profiling of serum
Time frame: 36 months
Proteomic characterization of serum will be analyzed by liquid chromatograph-mass spectrometer (LC/MS)
2 secondary outcomes
Body composition
Time frame: 36 months
Biochemical examination of blood samples
Time frame: 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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 Gut Microbiota, 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 2 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: withdrawn, as of the sponsor's last update on 13 Jun 2025. 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 was withdrawn before enrolling participants, so there are no results.
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 microbiota (time frame: 36 months). The study lists 3 primary outcomes in all. 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 13 Jun 2025.