<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/NCT03296267</url>
  </required_header>
  <id_info>
    <org_study_id>s56880</org_study_id>
    <nct_id>NCT03296267</nct_id>
  </id_info>
  <brief_title>Influence of Bile Acids on Bacterial Uptake in Functional Dyspepsia</brief_title>
  <official_title>Translocation of Microorganisms in Duodenal Biopsies of Healthy Volunteers and Patients With Functional Dyspepsia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</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>
      In up to half of patients seen by gastroenterologists, routine examinations fail to find an&#xD;
      underlying organic, systemic, or metabolic disease that readily explains the symptoms. These&#xD;
      patients are referred to as patients with disorders of gastrointestinal function, of which&#xD;
      functional dyspepsia (FD) is one of the most common. Despite intensive research to&#xD;
      investigate various pathophysiological mechanisms of this disease, the pathogenesis remains&#xD;
      obscure. The investigators recently demonstrated increased duodenal permeability in FD&#xD;
      patients, as assessed by mounting routine endoscopic duodenal biopsy specimens into Ussing&#xD;
      chambers to measure transepithelial electrical resistance and passage of a paracellular&#xD;
      fluorescent probe. Impaired intestinal barrier function can lead to increased uptake of&#xD;
      luminal substances which can induce an immunological response in the mucosa. Interestingly,&#xD;
      using transmission electron microscopy (TEM) in duodenal biopsies, the investigators recently&#xD;
      observed the presence of a yet to be identified microorganism inside the epithelium and the&#xD;
      lamina propria of a subset of FD patients (unpublished observations), suggesting increased&#xD;
      translocation of microorganisms.&#xD;
&#xD;
      The aim of the project is to investigate whether FD patients display increased translocation&#xD;
      of microorganisms in duodenal biopsies. The investigators will also test the effect of bile&#xD;
      acid on translocation of microorganisms and therefore include 20 FD patients and 20 age- and&#xD;
      gender-matched healthy volunteers in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants will be expected on the department endoscopy of the University Hospital&#xD;
      Gasthuisberg, Leuven, Belgium. They are asked to fill in a bundle of questionnaires&#xD;
      concerning physical complaints, depression, anxiety (disturbances), pain/disease,&#xD;
      body/interoceptive awareness, trauma/abuse and personality. Endoscopy will be performed and&#xD;
      up to 8 biopsies will be obtained from the duodenum. All endoscopies will be performed by an&#xD;
      experienced endoscopist. Biopsies will be mounted in Ussing chambers and the mucosal&#xD;
      compartment will be exposed to commercially available fluorescein-conjugated microorganisms.&#xD;
      Uptake of microorganisms will be evaluated by analyzing the serosal compartment and by&#xD;
      confocal microscopy of the biopsies. These experiments will also be performed in combination&#xD;
      with exposure to bile acids separately and jointly, to assess if bacterial translocation can&#xD;
      be exacerbated by these endogenous luminal factors individually and synergistically.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2, 2017</start_date>
  <completion_date type="Anticipated">April 20, 2018</completion_date>
  <primary_completion_date type="Anticipated">April 20, 2018</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>
  </study_design_info>
  <primary_outcome>
    <measure>Bacterial uptake in the duodenal biopsy measured by fluorescent intensity at the basolateral side of the ussing chamber setup.</measure>
    <time_frame>120 minutes</time_frame>
    <description>duodenal uptake of fluorescein conjugated microorganisms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>duodenal permeability assessed by measuring transepithelial electrical resistance in the Ussing chamber setup</measure>
    <time_frame>120 minutes</time_frame>
    <description>transepithelial electrical resistance</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Functional Dyspepsia</condition>
  <arm_group>
    <arm_group_label>gastroduodenoscopy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>all participants undergo a gastroduodenoscopy to use the biopsies in an Ussing chamber experiment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Gastroduodenoscopy</intervention_name>
    <description>Gastroduodenoscopy with duodenal biospies: A tube is placed via the mouth into the second part of the duodenum. Biopsy forceps is used to take duodenal biopsies.</description>
    <arm_group_label>gastroduodenoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Three days before the measurement: no smoking and drinking alcohol&#xD;
&#xD;
          -  12 hours before the measurement: no drinking and eating&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  symptoms or history of gastrointestinal disease&#xD;
&#xD;
          -  first degree relatives with celiac disease&#xD;
&#xD;
          -  diabetes mellitus&#xD;
&#xD;
          -  allergy/atopy (eczema, asthma, allergic rhinoconjunctivitis)&#xD;
&#xD;
          -  coagulation disorders/anticoagulant therapy&#xD;
&#xD;
          -  first degree relatives with Crohn's disease or type I diabetes mellitus.&#xD;
&#xD;
          -  intake of antihistamines, ketotifen, cromoglycate, acetylsalicylates, NSAIDs,&#xD;
             anticholinergics, theophylline, β2-agonists, codeine or opioid derivatives for at&#xD;
             least 2 weeks prior to the gastroscopy&#xD;
&#xD;
          -  Intake of steroid or immunosuppressive drugs in the last 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Tack, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>KU Leuven</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dorien Beeckmans, PhD</last_name>
    <phone>+3216 37 73 11</phone>
    <email>dorien.beeckmans@kuleuven.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>Translational Research center for Gastrointestinal Disorders (TARGID)</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dorien Beeckmans</last_name>
      <phone>+3216 37 73 11</phone>
      <email>dorien.beeckmans@kuleuven.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>October 4, 2017</last_update_submitted>
  <last_update_submitted_qc>October 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bile acid</keyword>
  <keyword>bacterial uptake</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspepsia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03296267
org study id: s56880
nct id: NCT03296267
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In up to half of patients seen by gastroenterologists, routine examinations fail to find an
      underlying organic, systemic, or metabolic disease that readily explains the symptoms. These
      patients are referred to as patients with disorders of gastrointestinal function, of which
      functional dyspepsia (FD) is one of the most common. Despite intensive research to
      investigate various pathophysiological mechanisms of this disease, the pathogenesis remains
      obscure. The investigators recently demonstrated increased duodenal permeability in FD
      patients, as assessed by mounting routine endoscopic duodenal biopsy specimens into Ussing
      chambers to measure transepithelial electrical resistance and passage of a paracellular
      fluorescent probe. Impaired intestinal barrier function can lead to increased uptake of
      luminal substances which can induce an immunological response in the mucosa. Interestingly,
      using transmission electron microscopy (TEM) in duodenal biopsies, the investigators recently
      observed the presence of a yet to be identified microorganism inside the epithelium and the
      lamina propria of a subset of FD patients (unpublished observations), suggesting increased
      translocation of microorganisms.

      The aim of the project is to investigate whether FD patients display increased translocation
      of microorganisms in duodenal biopsies. The investigators will also test the effect of bile
      acid on translocation of microorganisms and therefore include 20 FD patients and 20 age- and
      gender-matched healthy volunteers in this study.
The participants will be expected on the department endoscopy of the University Hospital
      Gasthuisberg, Leuven, Belgium. They are asked to fill in a bundle of questionnaires
      concerning physical complaints, depression, anxiety (disturbances), pain/disease,
      body/interoceptive awareness, trauma/abuse and personality. Endoscopy will be performed and
      up to 8 biopsies will be obtained from the duodenum. All endoscopies will be performed by an
      experienced endoscopist. Biopsies will be mounted in Ussing chambers and the mucosal
      compartment will be exposed to commercially available fluorescein-conjugated microorganisms.
      Uptake of microorganisms will be evaluated by analyzing the serosal compartment and by
      confocal microscopy of the biopsies. These experiments will also be performed in combination
      with exposure to bile acids separately and jointly, to assess if bacterial translocation can
      be exacerbated by these endogenous luminal factors individually and synergistically.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
measure: Bacterial uptake in the duodenal biopsy measured by fluorescent intensity at the basolateral side of the ussing chamber setup.
time frame: 120 minutes
description: duodenal uptake of fluorescein conjugated microorganisms
measure: duodenal permeability assessed by measuring transepithelial electrical resistance in the Ussing chamber setup
time frame: 120 minutes
description: transepithelial electrical resistance
arm group label: gastroduodenoscopy
arm group type: Other
description: all participants undergo a gastroduodenoscopy to use the biopsies in an Ussing chamber experiment.
intervention type: Procedure
intervention name: Gastroduodenoscopy
description: Gastroduodenoscopy with duodenal biospies: A tube is placed via the mouth into the second part of the duodenum. Biopsy forceps is used to take duodenal biopsies.
arm group label: gastroduodenoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jan Tack, Professor
role: Principal Investigator
affiliation: KU Leuven
last name: Dorien Beeckmans, PhD
phone: +3216 37 73 11
email: dorien.beeckmans@kuleuven.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Sponsor
mesh term: Dyspepsia
sharing ipd: No