xml: <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/NCT06013410</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0381</org_study_id>
      <nct_id>NCT06013410</nct_id>
    </id_info>
    <brief_title>Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome</brief_title>
    <acronym>IBS</acronym>
    <official_title>Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Jinhua Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Second Affiliated Hospital, School of Medicine, Zhejiang 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 goal of this clinical trial is to explore the pathophysiological effects of the&#xD;
        persistently colonized microbiome in irritable bowel syndrome (IBS) patients. The main&#xD;
        questions it aims to answer are:&#xD;
  &#xD;
        Question 1: the microbiome difference of the biofilm between IBS and healthy patients.&#xD;
  &#xD;
        Question 2: the metabolic product patterns between IBS and healthy patients.&#xD;
  &#xD;
        Participants will need to take a colonoscopy examination, two gut mucosal biopsy samples will&#xD;
        be collected during the examination.&#xD;
  &#xD;
        Researchers will compare the IBS and healthy control groups to see if there was the&#xD;
        disease-specific pattern in the microbiome and metabolic product of the biofilm.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 25, 2023</start_date>
    <completion_date type="Anticipated">May 15, 2026</completion_date>
    <primary_completion_date type="Anticipated">May 10, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>mirobiome difference of the fecal between IBS and health controls</measure>
      <time_frame>Fecal samples will be collected immediately before the colonoscopy (T1) and 7 days after the colonoscopy test (T2)</time_frame>
      <description>16S rDNA sequencing will be applied in fecal samples all the above participants</description>
    </primary_outcome>
    <primary_outcome>
      <measure>mirobiome difference of the fecal between IBS and health controls</measure>
      <time_frame>Fecal samples will be collected 7 days after the colonoscopy test (T2)</time_frame>
      <description>16S rDNA sequencing will be applied in fecal samples all the above participants</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Metabolic changes between IBS and Healthy controls</measure>
      <time_frame>1 day biopsy will be collected during the colonoscopy test</time_frame>
      <description>mucosal biopsy will be collected during the colonoscopy in each patients</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Irritable Bowel Syndrome</condition>
    <arm_group>
      <arm_group_label>IBS group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patients diagnosed with IBS according to clinical presentations</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>healthy control group</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>colonoscopy</intervention_name>
      <description>colonoscopy</description>
      <arm_group_label>IBS group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  IBS patients with IV type; no abdominal surgery;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  age &lt;18 y;&#xD;
  &#xD;
            -  major disease;&#xD;
  &#xD;
            -  alcoholic addicted;&#xD;
  &#xD;
            -  antibiotic use in past 3 months;&#xD;
  &#xD;
            -  severe gastrointestinal disease&#xD;
  &#xD;
            -  severe cardiac disease;&#xD;
  &#xD;
            -  pregnant;&#xD;
  &#xD;
            -  ICU in past 1 year;&#xD;
  &#xD;
            -  vegeterian;&#xD;
  &#xD;
            -  immune disease (SLE etc.)&#xD;
  &#xD;
            -  mental disease;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>WEI WEI</last_name>
      <phone>15267175186</phone>
      <email>wwze@zju.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>2ndAffiliated Hospital, School of Medicine, Zhejiang University</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>WEI WEI</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Irritable Bowel Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>share on request</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013410
  org study id: 2023-0381
  nct id: NCT06013410
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to explore the pathophysiological effects of the
        persistently colonized microbiome in irritable bowel syndrome (IBS) patients. The main
        questions it aims to answer are:
  
        Question 1: the microbiome difference of the biofilm between IBS and healthy patients.
  
        Question 2: the metabolic product patterns between IBS and healthy patients.
  
        Participants will need to take a colonoscopy examination, two gut mucosal biopsy samples will
        be collected during the examination.
  
        Researchers will compare the IBS and healthy control groups to see if there was the
        disease-specific pattern in the microbiome and metabolic product of the biofilm.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: Single (Participant)
  measure: mirobiome difference of the fecal between IBS and health controls
  time frame: Fecal samples will be collected immediately before the colonoscopy (T1) and 7 days after the colonoscopy test (T2)
  description: 16S rDNA sequencing will be applied in fecal samples all the above participants
  measure: mirobiome difference of the fecal between IBS and health controls
  time frame: Fecal samples will be collected 7 days after the colonoscopy test (T2)
  description: 16S rDNA sequencing will be applied in fecal samples all the above participants
  measure: Metabolic changes between IBS and Healthy controls
  time frame: 1 day biopsy will be collected during the colonoscopy test
  description: mucosal biopsy will be collected during the colonoscopy in each patients
  arm group label: IBS group
  arm group type: Experimental
  description: patients diagnosed with IBS according to clinical presentations
  arm group label: Healthy control group
  arm group type: No Intervention
  description: healthy control group
  intervention type: Diagnostic Test
  intervention name: colonoscopy
  description: colonoscopy
  arm group label: IBS group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: WEI WEI
  phone: 15267175186
  email: wwze@zju.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Irritable Bowel Syndrome
  mesh term: Syndrome
  sharing ipd: Undecided
  ipd description: share on request