<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04435548</url>
  </required_header>
  <id_info>
    <org_study_id>20190901ZJS0011</org_study_id>
    <nct_id>NCT04435548</nct_id>
  </id_info>
  <brief_title>Westlake Gut Microbiome Study</brief_title>
  <official_title>Multi-Omic Microbiome Study: Characterization of the Human Microbiota Among Chinese Population to Understant How the Microbiome Impacts Human Health.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Westlake University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Westlake University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Westlake Gut Microbiome study is a prospective cohort study. This project aims to&#xD;
      characterize the gut microbiome among Chinese populations from different regions of China,&#xD;
      and explore the relationships between gut microbiota and human health. Human fecal samples&#xD;
      will be collected from the participants and muli-omics detection and analysis will be&#xD;
      performed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the first phase of the study (also a pilot study), the investigators will create a&#xD;
      longitudinal datasets from a students-based cohort in Westlake University. Information about&#xD;
      demography, life style, diet, medical history, physical activity will be recorded, clinical&#xD;
      examinations such as blood glucose, body composition and electroencephalogram will be&#xD;
      examined, and biological samples including blood, saliva, urine and feces, will be collected.&#xD;
&#xD;
      In the second phase, the investigators will expand to include eligible participants from at&#xD;
      least 10 provinces of China, which are located at different regions. Similar to the&#xD;
      procedures in phase 1 stage, information about demography, life style, diet, medical history,&#xD;
      physical activity will be recorded, clinical examinations will be performed, and biological&#xD;
      samples will be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 1, 2021</start_date>
  <completion_date type="Anticipated">June 30, 2028</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Gut microbiota</measure>
    <time_frame>36 months</time_frame>
    <description>Fecal microbiome will be analyzed by 16S rRNA gene sequencing and metagenome sequencing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolomics of serum and gut microbiome</measure>
    <time_frame>36 months</time_frame>
    <description>Metabolomics of serum and gut microbiome will be analyzed by liquid chromatograph-mass spectrometer (LC/MS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proteomic profiling of serum</measure>
    <time_frame>36 months</time_frame>
    <description>Proteomic characterization of serum will be analyzed by liquid chromatograph-mass spectrometer (LC/MS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>36 months</time_frame>
    <description>Body composition will be analyzed using composition automatic analyzer at the time point of sample collection by compostion automatic analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical examination of blood samples</measure>
    <time_frame>36 months</time_frame>
    <description>Blood glucose, blood lipids, serum cytokines will be examined.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Gut Microbiota</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      venous blood, saliva, urine and feces.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All the participants should be Chinese residents, regardless of the ethics.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants or her/his legal guardian are able to report the antibiotics use during the&#xD;
        past 3 months; Participants or her/his legal guardian are able to understand and respond to&#xD;
        the online questionairs; Participants or her/his legal guardian are able and willing to&#xD;
        collect the biological samples as instructed; Participants or her/his legal guardian are&#xD;
        able and willing to provide written informed consent; -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Those with serious fundamental diseases or infectious diseases; and those with other&#xD;
        conditions that not suitable to participate in this study, as considered by the&#xD;
        investigators.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ju-Sheng Zheng, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Westlake University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Westlake University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310024</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Westlake University</investigator_affiliation>
    <investigator_full_name>Jusheng Zheng</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04435548
org study id: 20190901ZJS0011
nct id: NCT04435548
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Gut microbiota
time frame: 36 months
description: Fecal microbiome will be analyzed by 16S rRNA gene sequencing and metagenome sequencing.
measure: Metabolomics of serum and gut microbiome
time frame: 36 months
description: Metabolomics of serum and gut microbiome will be analyzed by liquid chromatograph-mass spectrometer (LC/MS)
measure: Proteomic profiling of serum
time frame: 36 months
description: Proteomic characterization of serum will be analyzed by liquid chromatograph-mass spectrometer (LC/MS)
measure: Body composition
time frame: 36 months
description: Body composition will be analyzed using composition automatic analyzer at the time point of sample collection by compostion automatic analyzer.
measure: Biochemical examination of blood samples
time frame: 36 months
description: Blood glucose, blood lipids, serum cytokines will be examined.
venous blood, saliva, urine and feces.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ju-Sheng Zheng, PhD
role: Principal Investigator
affiliation: Westlake University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Westlake University
investigator full name: Jusheng Zheng
investigator title: Dr
sharing ipd: Undecided