<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/NCT02249169</url>
  </required_header>
  <id_info>
    <org_study_id>14-000305</org_study_id>
    <nct_id>NCT02249169</nct_id>
  </id_info>
  <brief_title>Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome</brief_title>
  <official_title>Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This longitudinal study is being done to understand mechanisms underlying development of&#xD;
      irritable bowel syndrome (IBS) and the role of the gut bacteria in development of symptoms.&#xD;
      This information will be used to determine whether temporal changes in gut microbial taxonomy&#xD;
      and metabolism are associated with changes in symptom severity in IBS, and if targeted&#xD;
      dietary interventions, including prebiotics, can reverse or moderate these changes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2014</start_date>
  <completion_date type="Actual">February 8, 2017</completion_date>
  <primary_completion_date type="Actual">February 8, 2017</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>Change in gut microbiome in patients with IBS compared to healthy individuals measured over 6 months</measure>
    <time_frame>baseline, 6 months</time_frame>
    <description>Participants will provide a stool sample at baseline and at periodic intervals for 6 months to assess gut microbial composition.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">84</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>IBS-C</arm_group_label>
    <description>Patients with a clinical diagnosis of constipation-predominant irritable bowel syndrome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IBS-D</arm_group_label>
    <description>Patients with a clinical diagnosis of diarrhea-predominant irritable bowel syndrome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <description>Subjects without a clinical diagnosis of IBS-C or IBS-D</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <description>Subject without a clinical diagnosis of IBS-C or IBS-D and who is either a first-degree relative of an IBS participant or is not genetically related but resides with the IBS participant</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma, serum, whole blood, stool, colonic mucosal tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Motility Clinic, Clinical Research Unit, GI Department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        IBS-C and IBS-D SUBJECTS:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of IBS-C or IBS-D&#xD;
&#xD;
          -  Age 18 to 65&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior history of abdominal surgeries (except appendectomy and cholecystectomy)&#xD;
&#xD;
          -  Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or&#xD;
             other inflammatory condition&#xD;
&#xD;
          -  Antibiotic use within the past 4 weeks (they can be enrolled after a four-week washout&#xD;
             period and subsequent use during the 6-month study duration does not exclude them)&#xD;
&#xD;
          -  Bleeding risk or medications which may increase risk of bleeding for patients who&#xD;
             agree to undergo flexible sigmoidoscopy&#xD;
&#xD;
          -  Bowel preparation for colonoscopy within the past week&#xD;
&#xD;
          -  Pregnancy or plans to become pregnant within the study time frame&#xD;
&#xD;
          -  Vulnerable adults&#xD;
&#xD;
          -  Age greater than or equal to 66&#xD;
&#xD;
          -  Any other disease(s), condition(s) or habit(s) that would interfere with completion of&#xD;
             the study, would increase risks of flexible sigmoidoscopy (for those opting for this),&#xD;
             or in the judgment of the investigator would potentially interfere compliance to this&#xD;
             study or would adversely affect study outcomes&#xD;
&#xD;
        HEALTHY SUBJECTS:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 65&#xD;
&#xD;
          -  No clinical diagnosis of IBS-C or IBS-D&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior history of abdominal surgeries (except appendectomy and cholecystectomy)&#xD;
&#xD;
          -  Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or&#xD;
             other inflammatory condition&#xD;
&#xD;
          -  Antibiotic use within the past 4 weeks (they can be enrolled after a four-week washout&#xD;
             period and subsequent use during the 6-month study duration does not exclude them)&#xD;
&#xD;
          -  Bleeding risk or medications which may increase risk of bleeding for patients who&#xD;
             agree to undergo flexible sigmoidoscopy&#xD;
&#xD;
          -  Bowel preparation for colonoscopy within the past week&#xD;
&#xD;
          -  Pregnancy or plans to become pregnant within the study time frame&#xD;
&#xD;
          -  Vulnerable adults&#xD;
&#xD;
          -  Age greater than or equal to 66&#xD;
&#xD;
          -  Any other disease(s), condition(s) or habit(s) that would interfere with completion of&#xD;
             the study, would increase risks of flexible sigmoidoscopy (for those opting for this),&#xD;
             or in the judgment of the investigator would potentially interfere compliance to this&#xD;
             study or would adversely affect study outcomes&#xD;
&#xD;
          -  Clinical diagnosis of IBS-C or IBS-D&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Purna C. Kashyap, M.B.B.S.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>August 15, 2022</last_update_submitted>
  <last_update_submitted_qc>August 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Purna C. Kashyap, MBBS</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>IBS</keyword>
  <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>No</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/NCT02249169
org study id: 14-000305
nct id: NCT02249169
lead sponsor: 
collaborator: 
has dmc: No
This longitudinal study is being done to understand mechanisms underlying development of
      irritable bowel syndrome (IBS) and the role of the gut bacteria in development of symptoms.
      This information will be used to determine whether temporal changes in gut microbial taxonomy
      and metabolism are associated with changes in symptom severity in IBS, and if targeted
      dietary interventions, including prebiotics, can reverse or moderate these changes.
observational model: Case-Control
time perspective: Prospective
measure: Change in gut microbiome in patients with IBS compared to healthy individuals measured over 6 months
time frame: baseline, 6 months
description: Participants will provide a stool sample at baseline and at periodic intervals for 6 months to assess gut microbial composition.
arm group label: IBS-C
description: Patients with a clinical diagnosis of constipation-predominant irritable bowel syndrome
arm group label: IBS-D
description: Patients with a clinical diagnosis of diarrhea-predominant irritable bowel syndrome
arm group label: Healthy subjects
description: Subjects without a clinical diagnosis of IBS-C or IBS-D
arm group label: Healthy Controls
description: Subject without a clinical diagnosis of IBS-C or IBS-D and who is either a first-degree relative of an IBS participant or is not genetically related but resides with the IBS participant
Plasma, serum, whole blood, stool, colonic mucosal tissue
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Purna C. Kashyap, M.B.B.S.
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Purna C. Kashyap, MBBS
investigator title: PI
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome
sharing ipd: No