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/NCT06033222</url>
    </required_header>
    <id_info>
      <org_study_id>23-003520</org_study_id>
      <nct_id>NCT06033222</nct_id>
    </id_info>
    <brief_title>A Study of Perturbation of Human Small Intestinal Colonic Permeability</brief_title>
    <official_title>Developing an Approach to Perturbation of Human Small Intestinal and Colonic Permeability in Healthy Participants</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>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the effect of castor oil versus placebo on&#xD;
        intestinal permeability in healthy individuals.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
    <phase>Early Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Prospective randomized, placebo-control study of effect of castor oil on intestinal and colonic permeability</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in urinary excretion of 13^C-mannitol</measure>
      <time_frame>0-2 hours, 2-8 hours and 8-24 hours</time_frame>
      <description>Percent urinary excretion of 13^C-mannitol</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in urinary excretion of lactulose</measure>
      <time_frame>0-2 hours, 2-8 hours and 8-24 hours</time_frame>
      <description>Percent urinary excretion of lactulose</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>750 mg castor oil treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>1500 mg castor oil treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>3000 mg castor oil treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Subjects will take placebo daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Ricinoleic Acid 750 mg</intervention_name>
      <description>750 mg administered orally</description>
      <arm_group_label>750 mg castor oil treatment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Ricinoleic Acid 1500 mg</intervention_name>
      <description>1500 mg administered orally</description>
      <arm_group_label>1500 mg castor oil treatment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Ricinoleic Acid 3000 mg</intervention_name>
      <description>3000 mg administered orally</description>
      <arm_group_label>3000 mg castor oil treatment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Contains no active ingredient.</description>
      <arm_group_label>Placebo group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy, non-obese, non-pregnant volunteers.&#xD;
  &#xD;
            -  1:1 Male/Female Ratio.&#xD;
  &#xD;
            -  BMI &lt; 30 kg/m^2.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diabetes.&#xD;
  &#xD;
            -  Uncontrolled hypertension (with BP measured &gt; 140/90mmHg in the CRTU)&#xD;
  &#xD;
            -  BMI ≥ 30 kg/m^2.&#xD;
  &#xD;
            -  Chronic NSAID use (&gt; 1 day/week).&#xD;
  &#xD;
            -  Use of oral antibiotics for 2 weeks prior to and during the entire 5 day study period.&#xD;
  &#xD;
            -  Known intolerance of castor oil.&#xD;
  &#xD;
            -  Diagnosis of gastrointestinal diseases that are associated with abnormal intestinal or&#xD;
               colonic permeability such as inflammatory bowel diseases, irritable bowel syndrome and&#xD;
               celiac disease.&#xD;
  &#xD;
            -  Prior intestinal or colonic resection.&#xD;
  &#xD;
            -  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>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michael Camilleri, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <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>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>
    <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/NCT06033222
  org study id: 23-003520
  nct id: NCT06033222
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The purpose of this study is to evaluate the effect of castor oil versus placebo on
        intestinal permeability in healthy individuals.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective randomized, placebo-control study of effect of castor oil on intestinal and colonic permeability
  primary purpose: Other
  masking: Double (Participant, Investigator)
  measure: Change in urinary excretion of 13^C-mannitol
  time frame: 0-2 hours, 2-8 hours and 8-24 hours
  description: Percent urinary excretion of 13^C-mannitol
  measure: Change in urinary excretion of lactulose
  time frame: 0-2 hours, 2-8 hours and 8-24 hours
  description: Percent urinary excretion of lactulose
  arm group label: 750 mg castor oil treatment group
  arm group type: Experimental
  description: Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days
  arm group label: 1500 mg castor oil treatment group
  arm group type: Experimental
  description: Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days
  arm group label: 3000 mg castor oil treatment group
  arm group type: Experimental
  description: Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days
  arm group label: Placebo group
  arm group type: Placebo Comparator
  description: Subjects will take placebo daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days
  intervention type: Dietary Supplement
  intervention name: Ricinoleic Acid 750 mg
  description: 750 mg administered orally
  arm group label: 750 mg castor oil treatment group
  intervention type: Dietary Supplement
  intervention name: Ricinoleic Acid 1500 mg
  description: 1500 mg administered orally
  arm group label: 1500 mg castor oil treatment group
  intervention type: Dietary Supplement
  intervention name: Ricinoleic Acid 3000 mg
  description: 3000 mg administered orally
  arm group label: 3000 mg castor oil treatment group
  intervention type: Drug
  intervention name: Placebo
  description: Contains no active ingredient.
  arm group label: Placebo group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Michael Camilleri, MD
  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: Michael Camilleri, MD
  investigator title: Principal Investigator
  sharing ipd: No