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/NCT06028035</url>
    </required_header>
    <id_info>
      <org_study_id>23-005827</org_study_id>
      <nct_id>NCT06028035</nct_id>
    </id_info>
    <brief_title>A Study of Hemp Hull WFI for IBS Diarrhea</brief_title>
    <official_title>A Pilot Study of Hemp Hull WFI (BB01) to Reduce Intestinal Permeability in IBS-Diarrhea With Evidence of Bile Acid Diarrhea</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</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>
        The purpose of this study is the effect of a study bar, which contains 15 grams of insoluble&#xD;
        dietary fiber total sourced from Hemp hulls, on intestinal permeability in irritable bowel&#xD;
        syndrome (IBS)-bile acid diarrhea individuals.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in urinary excretion of 13^C-mannitol</measure>
      <time_frame>Baseline, 3 weeks</time_frame>
      <description>Percent urinary excretion of 13^C-mannitol</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in urinary excretion of lactulose</measure>
      <time_frame>Baseline, 3 weeks</time_frame>
      <description>Percent urinary excretion of lactulose</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Irritable Bowel Syndrome-bile Acid Diarrhea</condition>
    <arm_group>
      <arm_group_label>BB01 Supplement Bars</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will consume two BB01 supplement bars daily for 21 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>BB01</intervention_name>
      <description>20 grams minimally processed form of Hemp hulls in the form of a bar/wafer.</description>
      <arm_group_label>BB01 Supplement Bars</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria&#xD;
  &#xD;
            1. Prior diagnosis of bile acid diarrhea as documented by either&#xD;
  &#xD;
                 1. total bile acid in 48 hour stool excretion of 2337 micromoles per 48 hours, or&#xD;
  &#xD;
                 2. greater than 1000 micromoles per 48 hours with greater than 4% primary bile acids&#xD;
                    in stool, or&#xD;
  &#xD;
                 3. greater than 10% primary bile acid (CA and CDCA) in stool 48 hour collection, or&#xD;
  &#xD;
                 4. serum 7 alpha C4 greater than 52 ng/mL&#xD;
  &#xD;
            2. BMI &lt;40 kg/m2.&#xD;
  &#xD;
            3. Prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be&#xD;
               permissible for participation in the study.&#xD;
  &#xD;
            4. Participants receiving bile acid sequestrant will not be permitted to continue&#xD;
               therapy. and need to stop one week before baseline test.&#xD;
  &#xD;
            5. No use of oral antibiotics and NSAIDs for 2 weeks prior to study treatment&#xD;
  &#xD;
          Exclusion criteria&#xD;
  &#xD;
            1. Diabetes mellitus (type 1)&#xD;
  &#xD;
            2. Diabetes mellitus type 2 if taking metformin or GLP-1 agonist treatment (exenatide,&#xD;
               liraglutide, semaglutide)&#xD;
  &#xD;
            3. Uncontrolled hypertension (with BP measured &gt;140/90mmHg in the CRTU)&#xD;
  &#xD;
            4. BMI ≥40 kg/m2&#xD;
  &#xD;
            5. Chronic NSAID use (&gt;1 day/week)&#xD;
  &#xD;
            6. Use of oral antibiotics and NSAIDs for 2 weeks prior to and during the entire 21 day&#xD;
               study period&#xD;
  &#xD;
            7. Use of bile acid sequestrant for 1 week prior to and during the entire 21 day study&#xD;
               period&#xD;
  &#xD;
            8. Diagnosis of gastrointestinal diseases that are associated with inflammation such as&#xD;
               inflammatory bowel diseases and celiac disease or gastrointestinal infection in the&#xD;
               prior 4 weeks;&#xD;
  &#xD;
            9. Prior intestinal or colonic resection; note prior cholecystectomy, appendectomy, and&#xD;
               tubal ligation or hysterectomy will all be permissible for participation in the study&#xD;
  &#xD;
           10. Participation in highly vigorous exercise such as running &gt;5 miles per day in week&#xD;
               prior to the permeability test&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michael Camilleri, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Monique Ferber</last_name>
      <phone>507-538-6599</phone>
      <email>ferber.monique@mayo.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Irene Busciglio</last_name>
      <phone>507-266-6615</phone>
      <email>busciglio.irene@mayo.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Mayo Clinic Minnesota</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 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mayo Clinic</investigator_affiliation>
      <investigator_full_name>Michael Camilleri, MD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Irritable Bowel Syndrome</mesh_term>
      <mesh_term>Diarrhea</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/NCT06028035
  org study id: 23-005827
  nct id: NCT06028035
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is the effect of a study bar, which contains 15 grams of insoluble
        dietary fiber total sourced from Hemp hulls, on intestinal permeability in irritable bowel
        syndrome (IBS)-bile acid diarrhea individuals.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Change in urinary excretion of 13^C-mannitol
  time frame: Baseline, 3 weeks
  description: Percent urinary excretion of 13^C-mannitol
  measure: Change in urinary excretion of lactulose
  time frame: Baseline, 3 weeks
  description: Percent urinary excretion of lactulose
  arm group label: BB01 Supplement Bars
  arm group type: Experimental
  description: Subjects will consume two BB01 supplement bars daily for 21 days.
  intervention type: Dietary Supplement
  intervention name: BB01
  description: 20 grams minimally processed form of Hemp hulls in the form of a bar/wafer.
  arm group label: BB01 Supplement Bars
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Michael Camilleri, MD
  role: Principal Investigator
  affiliation: Mayo Clinic
  last name: Monique Ferber
  phone: 507-538-6599
  email: ferber.monique@mayo.edu
  last name: Irene Busciglio
  phone: 507-266-6615
  email: busciglio.irene@mayo.edu
  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: Michael Camilleri, MD
  investigator title: Principal Investigator
  mesh term: Irritable Bowel Syndrome
  mesh term: Diarrhea
  sharing ipd: No