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/NCT05972317</url>
    </required_header>
    <id_info>
      <org_study_id>1914-4</org_study_id>
      <nct_id>NCT05972317</nct_id>
    </id_info>
    <brief_title>The Stool Microbiome of Treated and Untreated IBS (Irritable Bowel Syndrome) Patients</brief_title>
    <official_title>Generating a Stool Microbiome-based Diagnostic for IBS (Irritable Bowel Syndrome) Patients in Low-FODMAP Treated and Untreated IBS Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Weizmann Institute of Science</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Weizmann Institute of Science</source>
    <oversight_info>
      <has_dmc>No</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>
        Irritable bowel syndrome (IBS) is considered the most common gastrointestinal disorder in&#xD;
        humans, with an estimated global prevalence of 11%-20% of all humans. Alterations in the gut&#xD;
        microbiome are at the center of IBS, and microbiome-induced volatile metabolites in response&#xD;
        to dietary exposures is believed to drive a downstream impact on susceptible hosts, thereby&#xD;
        driving the disease. However, the characteristics and functions of these metabolites remain&#xD;
        unknown to date. The two main mechanisms invoking IBS development and flares include 1) an&#xD;
        increase in luminal water content due to malabsorption of small molecules and 2)&#xD;
        incrementation of colon gas production generated by the fermentation of small molecules by&#xD;
        gut bacteria.Yet to date, a person-specific elucidation of the specific small molecules and&#xD;
        bacteria driving IBS, and their downstream effects on the human gut epithelium remain&#xD;
        unknown.&#xD;
  &#xD;
        Over the past years, it became evident that dietary regimes, and their interactions with the&#xD;
        intestinal microbiome, are at the center of IBS symptom generation and alleviation. The most&#xD;
        widely used dietary intervention is a highly restrictive diet, the low-Fermentable&#xD;
        Oligo-saccharides Di-saccharides Mono-saccharides And Polyols (FODMAP) diet, based on&#xD;
        avoidance of multiple food items that contain available fermentable molecules.&#xD;
  &#xD;
        The low-FODMAP diet remains an effective line of treatment for IBS patients, yet due to its&#xD;
        complexity and unhealthy nature, it remains a last line of treatment and fails to impact the&#xD;
        majority of IBS patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">November 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>IBS-SSS - irritable bowel syndrome severity score system questionnaire</measure>
      <time_frame>1 week</time_frame>
      <description>Severity of symptoms as they are scored in the Rome IV IBS-SSS 75 to &lt;175 to indicate mild IBS, 175 to &lt;300 as moderate, and &gt;300 as severe</description>
    </primary_outcome>
    <primary_outcome>
      <measure>IBS-QOL questionnaire - irritable bowel syndrome quality of life questionnaire</measure>
      <time_frame>1 week</time_frame>
      <description>Quality of life scores from the Rome IV IBS-QOL 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Stool microbiome differences between the study arms - using fecal samples of participants</measure>
      <time_frame>3 months</time_frame>
      <description>Analysis of stool samples of the different study arms - using shot-gun metagenomics to asses type of microbiota pre and post low-FODMAP diet.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Irritable Bowel Syndrome</condition>
    <arm_group>
      <arm_group_label>Non-IBS</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants which are not suffering from IBS symptoms.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>IBS -low FODMAP</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>individuals that are diagnosed with IBS according to Rome IV criteria</description>
    </arm_group>
    <arm_group>
      <arm_group_label>FODMAP graduates</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Individuals who have practiced a low-FODMAP diet in the past</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Low FODMAP dietary regimen</intervention_name>
      <description>intervention will include a guidance by a clinical dietitian about low FODMAP diet&#xD;
  The FODMAP diet has three phases:&#xD;
  Elimination - Avoidance from high-FODMAP foods (2-6 weeks)&#xD;
  Reintroduction -Structured challenges of specific food groups each time (6-8 weeks).&#xD;
  Maintenance - personalized diet, according to the response in step 2.</description>
      <arm_group_label>IBS -low FODMAP</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and Female&#xD;
  &#xD;
            -  Age - 18-70&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Consumption of antibiotics 2 months prior to the first day of the experiment.&#xD;
  &#xD;
            -  Consumption of probiotic supplements 1 month prior to the first day of the experiment.&#xD;
  &#xD;
            -  Type 1 or type 2 diabetes diagnosis.&#xD;
  &#xD;
            -  Pregnancy, fertility treatments, breastfeeding 3 months prior to the first day of the&#xD;
               study.&#xD;
  &#xD;
            -  Chronic disease - to the discretion of the study doctor.&#xD;
  &#xD;
            -  Cancer and recent anticancer treatment.&#xD;
  &#xD;
            -  Psychiatric disorders - to the discretion of the study doctor.&#xD;
  &#xD;
            -  IBD (inflammatory bowel diseases).&#xD;
  &#xD;
            -  Alcohol or substance abuse.&#xD;
  &#xD;
            -  BMI &gt; 35.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eran Elinav, Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>Weizmann Institute of Science</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yotam Cohen</last_name>
      <phone>+97289529173</phone>
      <email>Yotam.cohen@weizmann.ac.il</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shimrit Eliyahu Miller</last_name>
      <email>shimrit.miller@weizmann.ac.il</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>March 2, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 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>
    <!-- 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/NCT05972317
  org study id: 1914-4
  nct id: NCT05972317
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Irritable bowel syndrome (IBS) is considered the most common gastrointestinal disorder in
        humans, with an estimated global prevalence of 11%-20% of all humans. Alterations in the gut
        microbiome are at the center of IBS, and microbiome-induced volatile metabolites in response
        to dietary exposures is believed to drive a downstream impact on susceptible hosts, thereby
        driving the disease. However, the characteristics and functions of these metabolites remain
        unknown to date. The two main mechanisms invoking IBS development and flares include 1) an
        increase in luminal water content due to malabsorption of small molecules and 2)
        incrementation of colon gas production generated by the fermentation of small molecules by
        gut bacteria.Yet to date, a person-specific elucidation of the specific small molecules and
        bacteria driving IBS, and their downstream effects on the human gut epithelium remain
        unknown.
  
        Over the past years, it became evident that dietary regimes, and their interactions with the
        intestinal microbiome, are at the center of IBS symptom generation and alleviation. The most
        widely used dietary intervention is a highly restrictive diet, the low-Fermentable
        Oligo-saccharides Di-saccharides Mono-saccharides And Polyols (FODMAP) diet, based on
        avoidance of multiple food items that contain available fermentable molecules.
  
        The low-FODMAP diet remains an effective line of treatment for IBS patients, yet due to its
        complexity and unhealthy nature, it remains a last line of treatment and fails to impact the
        majority of IBS patients.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: IBS-SSS - irritable bowel syndrome severity score system questionnaire
  time frame: 1 week
  description: Severity of symptoms as they are scored in the Rome IV IBS-SSS 75 to <175 to indicate mild IBS, 175 to <300 as moderate, and >300 as severe
  measure: IBS-QOL questionnaire - irritable bowel syndrome quality of life questionnaire
  time frame: 1 week
  description: Quality of life scores from the Rome IV IBS-QOL 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life
  measure: Stool microbiome differences between the study arms - using fecal samples of participants
  time frame: 3 months
  description: Analysis of stool samples of the different study arms - using shot-gun metagenomics to asses type of microbiota pre and post low-FODMAP diet.
  arm group label: Non-IBS
  arm group type: No Intervention
  description: Participants which are not suffering from IBS symptoms.
  arm group label: IBS -low FODMAP
  arm group type: Experimental
  description: individuals that are diagnosed with IBS according to Rome IV criteria
  arm group label: FODMAP graduates
  arm group type: No Intervention
  description: Individuals who have practiced a low-FODMAP diet in the past
  intervention type: Other
  intervention name: Low FODMAP dietary regimen
  description: intervention will include a guidance by a clinical dietitian about low FODMAP diet
  The FODMAP diet has three phases:
  Elimination - Avoidance from high-FODMAP foods (2-6 weeks)
  Reintroduction -Structured challenges of specific food groups each time (6-8 weeks).
  Maintenance - personalized diet, according to the response in step 2.
  arm group label: IBS -low FODMAP
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Eran Elinav, Prof
  role: Principal Investigator
  affiliation: Weizmann Institute of Science
  last name: Yotam Cohen
  phone: +97289529173
  email: Yotam.cohen@weizmann.ac.il
  last name: Shimrit Eliyahu Miller
  email: shimrit.miller@weizmann.ac.il
  responsible party type: Sponsor
  mesh term: Irritable Bowel Syndrome
  mesh term: Syndrome