<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/NCT04497727</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201903360 -N</org_study_id>
    <secondary_id>R01HL132448</secondary_id>
    <nct_id>NCT04497727</nct_id>
  </id_info>
  <brief_title>Gut Organoid Study</brief_title>
  <official_title>Gut Inflammation and Gut-Gut Microbiome Interactions in the Pathogenesis of Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</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 study will compare basic properties of gut epithelia of hypertensive and normotensive&#xD;
      reference subjects. The study will determine if there are fundamental differences in the gut&#xD;
      epithelium in hypertension compared to normotension.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 5, 2021</start_date>
  <completion_date type="Anticipated">April 21, 2023</completion_date>
  <primary_completion_date type="Actual">April 8, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Samples with DNA</measure>
    <time_frame>Visit 1 day</time_frame>
    <description>Biopsy specimens (formalin fixed and paraffin embedded) which are routinely obtained during the endoscopic procedure are retained according to legal requirements.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">41</enrollment>
  <condition>Gut Inflammation</condition>
  <arm_group>
    <arm_group_label>Patients undergoing routine colonoscopy</arm_group_label>
    <description>Patients with and without hypertension who routinely undergo colonoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gene Expression</intervention_name>
    <description>Gene expression analysis of biopsy specimens obtained during routine colonoscopy examination</description>
    <arm_group_label>Patients undergoing routine colonoscopy</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      During your scheduled colonoscopy, a maximum of 4 biopsies will be taken from your colon.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Hypertensive and normotensive patients who routinely undergo scheduled elective colonoscopy&#xD;
        (for different, not selected reasons)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion/exclusion criteria for hypertension participants&#xD;
&#xD;
          -  Ages: 18-80 years old with a weight greater than or equal to 110 lbs&#xD;
&#xD;
          -  Diagnosis of hypertension or without hypertension for the reference cohort. 2017&#xD;
             ACC/AHA (American College of Cardiology/American Heart Association) definition for&#xD;
             hypertension (systolic blood pressure ≥130 mmHg and/or diastolic BP ≥80 mmHg) will be&#xD;
             used.&#xD;
&#xD;
          -  Scheduled elective colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypertensive or reference individuals with history of autoimmune disease or other&#xD;
             chronic inflammatory conditions.&#xD;
&#xD;
          -  Pregnant or have been pregnant in the last six months.&#xD;
&#xD;
          -  Antibiotic treatment within two months of study enrollment&#xD;
&#xD;
          -  Currently taking a medication (e.g. antibiotic, anti-inflammatory agents,&#xD;
             glucocorticoids, other immune modulating medications, antacids or proton pump&#xD;
             inhibitor drugs like Prilosec) known to modify gut microbiota.&#xD;
&#xD;
          -  Unwilling to discontinue using probiotics for at least two weeks before scheduled&#xD;
             biopsy.&#xD;
&#xD;
          -  History of intestinal surgery, inflammatory bowel disease, celiac disease, lactose&#xD;
             intolerance, chronic pancreatitis or other malabsorption disorder.&#xD;
&#xD;
          -  History of blood transfusion within 4 weeks.&#xD;
&#xD;
          -  Subjects who, in the opinion of the investigator, will be uncooperative or unable to&#xD;
             comply with study procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carl Pepine</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</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>Inflammation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04497727
org study id: IRB201903360 -N
secondary id: R01HL132448
nct id: NCT04497727
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will compare basic properties of gut epithelia of hypertensive and normotensive
      reference subjects. The study will determine if there are fundamental differences in the gut
      epithelium in hypertension compared to normotension.
observational model: Cohort
time perspective: Prospective
measure: Samples with DNA
time frame: Visit 1 day
description: Biopsy specimens (formalin fixed and paraffin embedded) which are routinely obtained during the endoscopic procedure are retained according to legal requirements.
arm group label: Patients undergoing routine colonoscopy
description: Patients with and without hypertension who routinely undergo colonoscopy
intervention type: Other
intervention name: Gene Expression
description: Gene expression analysis of biopsy specimens obtained during routine colonoscopy examination
arm group label: Patients undergoing routine colonoscopy
During your scheduled colonoscopy, a maximum of 4 biopsies will be taken from your colon.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carl Pepine
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Inflammation