<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/NCT01679730</url>
  </required_header>
  <id_info>
    <org_study_id>FEMH-100126-F</org_study_id>
    <nct_id>NCT01679730</nct_id>
  </id_info>
  <brief_title>Changes of Microbiota in Irritable Bowel Syndrome Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Far Eastern Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Far Eastern Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the changes of gastrointestinal microbiota in irritable bowel syndrome&#xD;
      patients by hydrogen breath test and molecular-based analysis of microbiota in&#xD;
      gastrointestinal tract&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <primary_completion_date type="Anticipated">April 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>difference in component of microbiota between cases and controls</measure>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Mucosa Associated Bacteria in Small Intestine</condition>
  <arm_group>
    <arm_group_label>irritable bowel syndrome patients</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Irritable bowel syndrome patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Case group: 20 to 80 years old irritable bowel syndrome patients&#xD;
&#xD;
          -  Control group: 20 to 80 years old healthy subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  without writtent informed consent&#xD;
&#xD;
          -  contraindications for enteroscopy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Chen-Shuan Chung, MD, M.Sc</last_name>
    <email>chungchenshuan_3@yahoo.com.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Far Eastern Memorial Hospital</name>
      <address>
        <city>New Taipei City</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chen-Shuan Chung, MD, M.Sc</last_name>
      <email>chugnchenshuan_3@yahoo.com.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>March 9, 2015</last_update_submitted>
  <last_update_submitted_qc>March 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01679730
org study id: FEMH-100126-F
nct id: NCT01679730
lead sponsor: 
has dmc: Yes
To investigate the changes of gastrointestinal microbiota in irritable bowel syndrome
      patients by hydrogen breath test and molecular-based analysis of microbiota in
      gastrointestinal tract
observational model: Case-Control
time perspective: Prospective
measure: difference in component of microbiota between cases and controls
arm group label: irritable bowel syndrome patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chen-Shuan Chung, MD, M.Sc
email: chungchenshuan_3@yahoo.com.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor