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/NCT05973500</url>
    </required_header>
    <id_info>
      <org_study_id>800805</org_study_id>
      <nct_id>NCT05973500</nct_id>
    </id_info>
    <brief_title>Effect of Mediterranean Diet in Inflammatory Bowel Disease</brief_title>
    <official_title>Implementing Metabolomics Informed Diet on Inflammatory Bowel Disease Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Diego</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, San Diego</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The effects of diet on inflammatory bowel disease is an under-studied area of research. The&#xD;
        investigators are interested in further investigating the role that diet contributes to&#xD;
        inflammatory bowel disease severity. The investigators will collect blood and stool samples&#xD;
        from patients with inflammatory bowel disease (IBD) before and after diet changes. The stool&#xD;
        samples will be analyzed using metabolomics and microbiome analysis to determine changes&#xD;
        after the new diet has been implemented. The investigators will then compare changes in the&#xD;
        patient's overall disease state by measuring markers of inflammation including C-reactive&#xD;
        protein (CRP) and fecal calprotectin to determine how this diet affects the disease state.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>short Crohn's Disease Activity Index (sCDAI)</measure>
      <time_frame>42 Days</time_frame>
      <description>Mild to moderate Crohn's Disease is defined by a short Crohn's Disease activity index (sCDAI) between 150-450, while those in remission from Crohn's Disease have an sCDAI score below 150. An sCDAI score exceeding 450 is used as a marker of severe Crohn's Disease.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Inflammatory Bowel Disease</condition>
    <arm_group>
      <arm_group_label>Mediterranean Diet</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Mediterranean Diet for 42 Days</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Mediterranean Diet</intervention_name>
      <description>Mediterranean Diet for 42 Days</description>
      <arm_group_label>Mediterranean Diet</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years old or older&#xD;
  &#xD;
            -  Meet classification criteria for inflammatory bowel disease including those with mild&#xD;
               to moderate Crohn's Disease as defined by a Crohn's disease activity index between&#xD;
               150-450, with fecal calprotectin&gt;250, within 1 month of enrollment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to provide informed consent&#xD;
  &#xD;
            -  History of or current drug abuse&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Start or change in dose of standard-of-care treatment within 12 weeks of the screening&#xD;
  &#xD;
            -  Known allergy to any component of the proposed diet&#xD;
  &#xD;
            -  Subjects with significant other medical or psychiatric comorbidities and /or&#xD;
               medication use which in&#xD;
  &#xD;
            -  physician's clinical judgment might difficult the interpretation of the results&#xD;
  &#xD;
            -  Patients that are not on a stable dose of medications, for instance, steroids, in&#xD;
               between samples collection&#xD;
  &#xD;
            -  Patients on antibiotics&#xD;
  &#xD;
            -  Patients with C difficile infection within 4 weeks of enrollment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Monica Guma, M.D., PhD</last_name>
      <phone>8588226523</phone>
      <email>mguma@health.ucsd.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mehrnaz Aghili, M.D.</last_name>
      <phone>8583991225</phone>
      <email>maghili@health.ucsd.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of California, San Diego</name>
        <address>
          <city>San Diego</city>
          <state>California</state>
          <zip>92161</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Monica Guma, M.D, PHD</last_name>
        <email>mguma@health.ucsd.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of California, San Diego</investigator_affiliation>
      <investigator_full_name>Monica Guma</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intestinal Diseases</mesh_term>
      <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05973500
  org study id: 800805
  nct id: NCT05973500
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The effects of diet on inflammatory bowel disease is an under-studied area of research. The
        investigators are interested in further investigating the role that diet contributes to
        inflammatory bowel disease severity. The investigators will collect blood and stool samples
        from patients with inflammatory bowel disease (IBD) before and after diet changes. The stool
        samples will be analyzed using metabolomics and microbiome analysis to determine changes
        after the new diet has been implemented. The investigators will then compare changes in the
        patient's overall disease state by measuring markers of inflammation including C-reactive
        protein (CRP) and fecal calprotectin to determine how this diet affects the disease state.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: short Crohn's Disease Activity Index (sCDAI)
  time frame: 42 Days
  description: Mild to moderate Crohn's Disease is defined by a short Crohn's Disease activity index (sCDAI) between 150-450, while those in remission from Crohn's Disease have an sCDAI score below 150. An sCDAI score exceeding 450 is used as a marker of severe Crohn's Disease.
  arm group label: Mediterranean Diet
  arm group type: Experimental
  description: Mediterranean Diet for 42 Days
  intervention type: Dietary Supplement
  intervention name: Mediterranean Diet
  description: Mediterranean Diet for 42 Days
  arm group label: Mediterranean Diet
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Monica Guma, M.D., PhD
  phone: 8588226523
  email: mguma@health.ucsd.edu
  last name: Mehrnaz Aghili, M.D.
  phone: 8583991225
  email: maghili@health.ucsd.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of California, San Diego
  investigator full name: Monica Guma
  investigator title: Associate Professor
  mesh term: Intestinal Diseases
  mesh term: Inflammatory Bowel Diseases
  sharing ipd: No