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/NCT05972694</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY20230070</org_study_id>
      <nct_id>NCT05972694</nct_id>
    </id_info>
    <brief_title>Effect of Grapes in Inflammatory Bowel Disease</brief_title>
    <official_title>The Effect of Grapes in Inflammatory Bowel Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Case Western Reserve University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>California Table Grape Commission</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Case Western Reserve 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 overall objective of this pilot intervention study is to determine the impact of grape&#xD;
        powder (46g/day freeze dried whole grape powder provided by the California Table Grape&#xD;
        Commission) on the gut microbiotacomposition in adult patients with the IBD subtype Crohn's&#xD;
        disease (CD).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This protocol is designed to investigate the effect of grape powder consumption in&#xD;
        Inflammatory Bowel Disease (IBD), in particular how grape powder consumption (provided as&#xD;
        46g/day grape powder; equivalent to 1.5 cups fresh grapes) alters the gut microbiota (GM)&#xD;
        composition in humans with IBD. The investigators will focus on studying IBD patients&#xD;
        affected with CD as a proof of principle that could be tested later in other IBD subtype&#xD;
        (ulcerative colitis or others specific surgical conditions).&#xD;
  &#xD;
        The overall objective of this pilot intervention study is to determine the impact of grape&#xD;
        powder (46g/day freeze dried whole grape powder provided by the California Table Grape&#xD;
        Commission) on the GM composition in adult patients with the IBD subtype Crohn's disease&#xD;
        (CD).&#xD;
  &#xD;
        An 8-week pilot study in adult CD patients at the Digestive Health Institutes (DHI) of&#xD;
        University Hospitals Cleveland Medical Center (UHCMC). table&#xD;
  &#xD;
        Participation in this study will last for a maximum of 56 days and will consist of two&#xD;
        phases. Phase I (baseline period - 21-28 days) where all grapes and berries will be removed&#xD;
        from the diet, and Phase II (intervention period - 28 days) where participants will be&#xD;
        supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily. The&#xD;
        dose of 46g/day of grape powder is equivalent to 1.5 cups of grapes. Participants will be&#xD;
        asked to avoid consumption of all other grapes/berries during phase II. The investigators&#xD;
        will compare the before and after changes in gut microbiota composition.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">April 2, 2024</start_date>
    <completion_date type="Anticipated">October 2, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2, 2025</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>
      <intervention_model_description>subjects will continue to consume their usual diet (excluding all grapes/berries) and consume 46g/d freeze-dried grape powder daily (consumed as 22.5g packets twice daily for 28 days. A stool, urine and blood sample will be collected at the start and end of the intervention..</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>fecal microbiota composition</measure>
      <time_frame>baseline (pre-intervention), immediately after the intervention</time_frame>
      <description>16S microbiome</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>fecal myleoperoxidase (MPO)</measure>
      <time_frame>baseline (pre-intervention), immediately after the intervention</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fecal calprotectin</measure>
      <time_frame>baseline (pre-intervention), immediately after the intervention</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Crohns Disease Activity Index</measure>
      <time_frame>baseline (pre-intervention), immediately after the intervention</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C-reactive protein (CRP)</measure>
      <time_frame>baseline (pre-intervention), immediately after the intervention</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Crohn Disease</condition>
    <arm_group>
      <arm_group_label>Freeze-dried Grape powder intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily for 28 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Freeze dried grape powder</intervention_name>
      <description>46g/d freeze-dried grape powder</description>
      <arm_group_label>Freeze-dried Grape powder intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Documented diagnosis of Crohns disease. CD outpatients in remission&#xD;
  &#xD;
            -  Harvey Bradshaw-index in remission (&lt;5 score)&#xD;
  &#xD;
            -  Capable of providing consent to participate.&#xD;
  &#xD;
            -  Able to complete daily surveys and take oral nutrition&#xD;
  &#xD;
            -  Able to record daily meal intake&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Short bowel syndrome.&#xD;
  &#xD;
            -  Hospitalized patients.&#xD;
  &#xD;
            -  Individuals who lack consent capacity, including the mentally ill, prisoners,&#xD;
               cognitively impaired participants, dementia patients.&#xD;
  &#xD;
            -  Known drug abuse.&#xD;
  &#xD;
            -  Known parasitic disease of the digestive system.&#xD;
  &#xD;
            -  Symptomatic intestinal stricture.&#xD;
  &#xD;
            -  Presence of an ostomy.&#xD;
  &#xD;
            -  Other conditions that would be a contraindication to consumption of the study diets or&#xD;
               preclude the participant from completing the study.&#xD;
  &#xD;
            -  Well-founded doubt about the patients cooperation.&#xD;
  &#xD;
            -  Existing pregnancy or lactation.&#xD;
  &#xD;
            -  History of &lt;1 natural bowel movements per day.&#xD;
  &#xD;
            -  Unable to access to technology that permits the daily completion of study related&#xD;
               activities.&#xD;
  &#xD;
            -  Change in IBD medication within past 4 weeks.&#xD;
  &#xD;
            -  Body mass Index &lt;16 kg/m or ≥35.&#xD;
  &#xD;
            -  Documented C.difficile colitis within four weeks of screening.&#xD;
  &#xD;
            -  Known berry or grape allergy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Abigail Basson, PhD</last_name>
      <phone>8562203445</phone>
      <email>abigail.basson@uhhospitals.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Megan Luskin</last_name>
      <phone>216-368-2440</phone>
      <email>mluskin@case.edu</email>
    </overall_contact_backup>
    <link>
      <url>http://www.grapesfromcalifornia.com/</url>
      <description>California Table Grape Commission</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Case Western Reserve University</investigator_affiliation>
      <investigator_full_name>Abigail Basson</investigator_full_name>
      <investigator_title>Principal Investigator, study coordinator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Crohn Disease</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/NCT05972694
  org study id: STUDY20230070
  nct id: NCT05972694
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The overall objective of this pilot intervention study is to determine the impact of grape
        powder (46g/day freeze dried whole grape powder provided by the California Table Grape
        Commission) on the gut microbiotacomposition in adult patients with the IBD subtype Crohn's
        disease (CD).
  This protocol is designed to investigate the effect of grape powder consumption in
        Inflammatory Bowel Disease (IBD), in particular how grape powder consumption (provided as
        46g/day grape powder; equivalent to 1.5 cups fresh grapes) alters the gut microbiota (GM)
        composition in humans with IBD. The investigators will focus on studying IBD patients
        affected with CD as a proof of principle that could be tested later in other IBD subtype
        (ulcerative colitis or others specific surgical conditions).
  
        The overall objective of this pilot intervention study is to determine the impact of grape
        powder (46g/day freeze dried whole grape powder provided by the California Table Grape
        Commission) on the GM composition in adult patients with the IBD subtype Crohn's disease
        (CD).
  
        An 8-week pilot study in adult CD patients at the Digestive Health Institutes (DHI) of
        University Hospitals Cleveland Medical Center (UHCMC). table
  
        Participation in this study will last for a maximum of 56 days and will consist of two
        phases. Phase I (baseline period - 21-28 days) where all grapes and berries will be removed
        from the diet, and Phase II (intervention period - 28 days) where participants will be
        supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily. The
        dose of 46g/day of grape powder is equivalent to 1.5 cups of grapes. Participants will be
        asked to avoid consumption of all other grapes/berries during phase II. The investigators
        will compare the before and after changes in gut microbiota composition.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: subjects will continue to consume their usual diet (excluding all grapes/berries) and consume 46g/d freeze-dried grape powder daily (consumed as 22.5g packets twice daily for 28 days. A stool, urine and blood sample will be collected at the start and end of the intervention..
  primary purpose: Other
  masking: None (Open Label)
  measure: fecal microbiota composition
  time frame: baseline (pre-intervention), immediately after the intervention
  description: 16S microbiome
  measure: fecal myleoperoxidase (MPO)
  time frame: baseline (pre-intervention), immediately after the intervention
  measure: fecal calprotectin
  time frame: baseline (pre-intervention), immediately after the intervention
  measure: Crohns Disease Activity Index
  time frame: baseline (pre-intervention), immediately after the intervention
  measure: C-reactive protein (CRP)
  time frame: baseline (pre-intervention), immediately after the intervention
  arm group label: Freeze-dried Grape powder intervention
  arm group type: Experimental
  description: participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily for 28 days.
  intervention type: Dietary Supplement
  intervention name: Freeze dried grape powder
  description: 46g/d freeze-dried grape powder
  arm group label: Freeze-dried Grape powder intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Abigail Basson, PhD
  phone: 8562203445
  email: abigail.basson@uhhospitals.org
  last name: Megan Luskin
  phone: 216-368-2440
  email: mluskin@case.edu
  url: http://www.grapesfromcalifornia.com/
  description: California Table Grape Commission
  responsible party type: Principal Investigator
  investigator affiliation: Case Western Reserve University
  investigator full name: Abigail Basson
  investigator title: Principal Investigator, study coordinator
  mesh term: Crohn Disease
  mesh term: Inflammatory Bowel Diseases
  sharing ipd: No