<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/NCT03003234</url>
  </required_header>
  <id_info>
    <org_study_id>Bile acid-permeability</org_study_id>
    <nct_id>NCT03003234</nct_id>
  </id_info>
  <brief_title>Association Between Luminal Bile Salt Content and Duodenal Mucosal Integrity in Functional Dyspepsia</brief_title>
  <official_title>Association Between Luminal Bile Salt Content and Duodenal Mucosal Integrity in 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Functional dyspepsia (FD) is an extremely common disorder of gastrointestinal function.&#xD;
      Recently, impaired duodenal mucosal integrity was reported as a potential pathophysiological&#xD;
      mechanism in FD. However, the factors controlling duodenal mucosal integrity remain unknown.&#xD;
      In this study, we evaluated whether the luminal bile salt content could play a role in&#xD;
      impaired duodenal permeability in FD.&#xD;
&#xD;
      Duodenal biopsies were obtained from 25 healthy volunteers (HV) and 25 FD patients. Biopsies&#xD;
      were mounted in Ussing chambers to measure transepithelial resistance (TEER) and paracellular&#xD;
      permeability using fluorescein isothiocyanate dextran (FITC-dx4, MW 4kDa). Expression of bile&#xD;
      acid-sensing receptors (TGR5, VDR, PXR, FXR and CAR) in duodenal biopsies was measured by&#xD;
      western blot and real time RT-PCR. Immunohistochemistry was used to evaluate eosinophil and&#xD;
      mastcell infiltration in duodenal biopsies of FD patients and HV. Duodenal fluid aspirates&#xD;
      were collected at fixed time points during 1 hour in fasted state and 1.5 hours after a&#xD;
      liquid meal (Nutridrink, 200ml). Concentration and composition of the bile salt pool&#xD;
      (including glycocholic acid (GC), taurocholic acid (TC), glycochenodeoxycholic acid (GCDC),&#xD;
      taurochenodeoxycholic acid (TCDC), glycodeoxycholic acid (GDC), taurodeoxycholic acid (TDC),&#xD;
      glycoursodeoxycholic acid (GUDC) and tauroursodeoxycholic acid (TUDC)) in these aspirates was&#xD;
      evaluated by liquid chromatography-mass spectrometry-selected ion monitoring analysis&#xD;
      (LC-MS/MS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Rome III criteria defined functional dyspepsia (FD) as the presence of symptoms thought&#xD;
      to originate in the gastroduodenal region, in the absence of any organic, systemic or&#xD;
      metabolic disease that readily explains the complaints. FD is extremely common, affecting up&#xD;
      to 15-20% of the population and is associated with significantly decreased quality of life&#xD;
      and substantial healthcare costs. The available treatment options for FD are of limited&#xD;
      effectiveness, which reflects the poorly understood pathogenesis. Studies indicate that FD is&#xD;
      a heterogeneous disorder, in which different pathophysiological mechanisms underlie specific&#xD;
      symptom patterns. Traditionally, gastric abnormalities such as impaired accommodation,&#xD;
      delayed emptying and hypersensitivity have been believed to be involved in the&#xD;
      pathophysiology of FD. More recent studies have suggested that also a number of duodenal&#xD;
      abnormalities can be responsible for the generation of symptoms, like increased sensitivity&#xD;
      to duodenal acid, increased sensitivity to duodenal lipids and low-grade mucosal&#xD;
      inflammation.&#xD;
&#xD;
      The investigators recently showed that FD patients display impaired duodenal mucosal&#xD;
      integrity. The trigger of increased permeability is unknown, but it is possible that&#xD;
      increased exposure to duodenal bile acids or an altered composition of bile acids leads to&#xD;
      impairment of the intestinal barrier. This sustained enhancement of paracellular permeability&#xD;
      could facilitate the constant passage of luminal antigens through the mucosa and lead to&#xD;
      local mucosal immune responses that manifest as inflammation and finally result in generation&#xD;
      of dyspeptic symptoms.&#xD;
&#xD;
      The investigators hypothesized that increased duodenal bile acid exposure or a change in the&#xD;
      composition of bile acids lead to impaired duodenal mucosal integrity in FD, allowing luminal&#xD;
      substances to pass through the mucosa and result in immune responses and finally in dyspeptic&#xD;
      symptom generation. The general aim of this project is to assess if FD patients display&#xD;
      increased endogenous duodenal bile acid exposure and a different bile acid composition. In&#xD;
      addition, it will be tested whether duodenal mucosal permeability of FD patients with an&#xD;
      endogenous duodenal bile acid exposure above the normal range and an altered bile acid&#xD;
      composition is higher than in FD patients with a normal endogenous duodenal acid exposure and&#xD;
      composition.&#xD;
&#xD;
      Participants will be expected on the department endoscopy of the UZ Gasthuisberg after they&#xD;
      have fasted overnight. Before the study, 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.&#xD;
&#xD;
      Gastroduodenoscopy will be performed by an experienced endoscopist (Jan Tack). Hereby, 12&#xD;
      duodenal biopsies (2 biopsies at a time) (Radial Jaw™3 with needle; outside diameter 2.2mm;&#xD;
      Boston Scientific, 302 Parkway, Global Park, Heredia, Costa Rica) will be obtained. To&#xD;
      measure the in vitro transepithelial resistance, 4 biopsies will be examined using an adapted&#xD;
      mini-Ussing chambers system. After equilibration, the mucosal side of the tissue will be&#xD;
      exposed to 4kDa FITC-dextran as a measure of paracellular permeability. A sample will be&#xD;
      taken from the serosal side during 2h at 30min interval. The concentration of fluorescein&#xD;
      will then be measured using a fluorescence plate reader. Also, 2 biopsies will be used for&#xD;
      mRNA extraction and subsequent cDNA synthesis. This cDNA will be used to measure the gene&#xD;
      expression of cell-to-cell adhesion proteins and acid-sensing receptors by means of real-time&#xD;
      PCR. In addition, 2 biopsies will be prepared for immunofluorescence and immunohistochemistry&#xD;
      and 2 will be used for western blot to measure changes in distribution/expression of the&#xD;
      cell-to-cell adhesion proteins and of bile acid-sensitive receptors. Two biopsies will be&#xD;
      obtained to study ultrastructural alterations by transmission electron microscopy.&#xD;
&#xD;
      After recovery, a catheter will be introduced in the second duodenum via the nose and the&#xD;
      position of the catheter will be checked fluoroscopically. This catheter allows collection of&#xD;
      intestinal fluids by means of a syringe to collect duodenal fluid aspirates and&#xD;
      characterization of the bile acid composition of those samples (8). After 30 minutes, the&#xD;
      participants will be given a specified amount of water (250 mL) (fasted state) and another 30&#xD;
      minutes later a nutritional drink (fed state). Intestinal fluids will be sampled every 15 min&#xD;
      for a period of 1 h before the liquid meal intake and until 90 minutes after the liquid meal&#xD;
      intake. So, after the total collection period, 7 fractions for the fed state and 4 fractions&#xD;
      for the fasted state will be obtained per participant in a time frame of 2 hours and a half.&#xD;
      The composition of bile acids of the intestinal samples will be determined by GC-MS-selected&#xD;
      ion monitoring analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</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>Duodenal mucosal transepithelial electrical resistance (Ohm*cm^2)</measure>
    <time_frame>2 hours</time_frame>
    <description>Measurement for mucosal integrity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duodenal paracellular passage of Fitc Dextran 4 kDa (pmol)</measure>
    <time_frame>2 hours</time_frame>
    <description>Measurement for mucosal integrity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycocholic acid concentration (mM)</measure>
    <time_frame>2.5 hours</time_frame>
    <description>Bile salt</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Taurocholic acid concentration (mM)</measure>
    <time_frame>2.5 hours</time_frame>
    <description>Bile salt</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycochenodeoxycholic acid concentration (mM)</measure>
    <time_frame>2.5 hours</time_frame>
    <description>Bile salt</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Taurochenodeoxycholic acid concentration (mM)</measure>
    <time_frame>2.5 hours</time_frame>
    <description>Bile salt</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycodeoxycholic acid concentration (mM)</measure>
    <time_frame>2.5 hours</time_frame>
    <description>Bile salt</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Taurodeoxycholic acid concentration (mM)</measure>
    <time_frame>2.5 hours</time_frame>
    <description>Bile salt</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycoursodeoxycholic acid concentration (mM)</measure>
    <time_frame>2.5 hours</time_frame>
    <description>Bile salt</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tauroursodeoxycholic acid concentration (mM)</measure>
    <time_frame>2.5 hours</time_frame>
    <description>Bile salt</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duodenal mucosal mastcell count (number of mastcells/mm^2 lamina propria)</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duodenal mucosal eosinophil count (number of eosinophils/mm^2 lamina propria)</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RNA expression of Vitamin D receptor (VDR)</measure>
    <time_frame>2 years</time_frame>
    <description>Real-time RT-PCR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RNA expression of bile acid receptor FXR</measure>
    <time_frame>2 years</time_frame>
    <description>Real-time RT-PCR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RNA expression of bile acid receptor PXR</measure>
    <time_frame>2 years</time_frame>
    <description>Real-time RT-PCR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RNA expression of bile acid receptor TGR5</measure>
    <time_frame>2 years</time_frame>
    <description>Real-time RT-PCR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RNA expression of bile acid receptor CAR</measure>
    <time_frame>2 years</time_frame>
    <description>Real-time RT-PCR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protein expression of bile acid receptor VDR</measure>
    <time_frame>2 years</time_frame>
    <description>Western blot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protein expression of bile acid receptor FXR</measure>
    <time_frame>2 years</time_frame>
    <description>Western blot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protein expression of bile acid receptor PXR</measure>
    <time_frame>2 years</time_frame>
    <description>Western blot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protein expression of bile acid receptor TGR5</measure>
    <time_frame>2 years</time_frame>
    <description>Western blot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protein expression of bile acid receptor CAR</measure>
    <time_frame>2 years</time_frame>
    <description>Western blot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stomach complaints questionnaire</measure>
    <time_frame>2 years</time_frame>
    <description>Questions about stomach complaints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ReQuest Questionnaire</measure>
    <time_frame>2 years</time_frame>
    <description>Reflux evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Council of Nutrition appetite questionnaire</measure>
    <time_frame>2 years</time_frame>
    <description>Questions about appetite</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel complaints questionnaire</measure>
    <time_frame>2 years</time_frame>
    <description>Questions about bowel complaints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient health questionnaire</measure>
    <time_frame>2 years</time_frame>
    <description>Questions about health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety sensitivity index</measure>
    <time_frame>2 years</time_frame>
    <description>Questions about anxiety sensitivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visceral sensitivity index</measure>
    <time_frame>2 years</time_frame>
    <description>Questions about visceral sensitivity</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Functional Dyspepsia</condition>
  <arm_group>
    <arm_group_label>Duodenal fluid aspiration</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Duodenogastroscopy</intervention_name>
    <description>Catheter goes through the mouth in the duodenum to take duodenal biopsies.</description>
    <arm_group_label>Duodenal fluid aspiration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Duodenal aspiration catheter</intervention_name>
    <description>Catheter goes through the nose in the duodenum to aspirate duodenal fluid in fasted and fed state.</description>
    <arm_group_label>Duodenal fluid aspiration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutri drink</intervention_name>
    <description>Liquid meal of 200 ml.</description>
    <arm_group_label>Duodenal fluid aspiration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  FD patients have to fulfill the Rome III criteria for functional dyspepsia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Symptoms or history of gastrointestinal disease (for healthy volunteers)&#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 study.&#xD;
&#xD;
          -  Steroid or immunosuppressive drug intake any time 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>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>December 23, 2016</last_update_submitted>
  <last_update_submitted_qc>December 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 26, 2016</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>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/NCT03003234
org study id: Bile acid-permeability
nct id: NCT03003234
lead sponsor: 
has dmc: No
Functional dyspepsia (FD) is an extremely common disorder of gastrointestinal function.
      Recently, impaired duodenal mucosal integrity was reported as a potential pathophysiological
      mechanism in FD. However, the factors controlling duodenal mucosal integrity remain unknown.
      In this study, we evaluated whether the luminal bile salt content could play a role in
      impaired duodenal permeability in FD.

      Duodenal biopsies were obtained from 25 healthy volunteers (HV) and 25 FD patients. Biopsies
      were mounted in Ussing chambers to measure transepithelial resistance (TEER) and paracellular
      permeability using fluorescein isothiocyanate dextran (FITC-dx4, MW 4kDa). Expression of bile
      acid-sensing receptors (TGR5, VDR, PXR, FXR and CAR) in duodenal biopsies was measured by
      western blot and real time RT-PCR. Immunohistochemistry was used to evaluate eosinophil and
      mastcell infiltration in duodenal biopsies of FD patients and HV. Duodenal fluid aspirates
      were collected at fixed time points during 1 hour in fasted state and 1.5 hours after a
      liquid meal (Nutridrink, 200ml). Concentration and composition of the bile salt pool
      (including glycocholic acid (GC), taurocholic acid (TC), glycochenodeoxycholic acid (GCDC),
      taurochenodeoxycholic acid (TCDC), glycodeoxycholic acid (GDC), taurodeoxycholic acid (TDC),
      glycoursodeoxycholic acid (GUDC) and tauroursodeoxycholic acid (TUDC)) in these aspirates was
      evaluated by liquid chromatography-mass spectrometry-selected ion monitoring analysis
      (LC-MS/MS).
The Rome III criteria defined functional dyspepsia (FD) as the presence of symptoms thought
      to originate in the gastroduodenal region, in the absence of any organic, systemic or
      metabolic disease that readily explains the complaints. FD is extremely common, affecting up
      to 15-20% of the population and is associated with significantly decreased quality of life
      and substantial healthcare costs. The available treatment options for FD are of limited
      effectiveness, which reflects the poorly understood pathogenesis. Studies indicate that FD is
      a heterogeneous disorder, in which different pathophysiological mechanisms underlie specific
      symptom patterns. Traditionally, gastric abnormalities such as impaired accommodation,
      delayed emptying and hypersensitivity have been believed to be involved in the
      pathophysiology of FD. More recent studies have suggested that also a number of duodenal
      abnormalities can be responsible for the generation of symptoms, like increased sensitivity
      to duodenal acid, increased sensitivity to duodenal lipids and low-grade mucosal
      inflammation.

      The investigators recently showed that FD patients display impaired duodenal mucosal
      integrity. The trigger of increased permeability is unknown, but it is possible that
      increased exposure to duodenal bile acids or an altered composition of bile acids leads to
      impairment of the intestinal barrier. This sustained enhancement of paracellular permeability
      could facilitate the constant passage of luminal antigens through the mucosa and lead to
      local mucosal immune responses that manifest as inflammation and finally result in generation
      of dyspeptic symptoms.

      The investigators hypothesized that increased duodenal bile acid exposure or a change in the
      composition of bile acids lead to impaired duodenal mucosal integrity in FD, allowing luminal
      substances to pass through the mucosa and result in immune responses and finally in dyspeptic
      symptom generation. The general aim of this project is to assess if FD patients display
      increased endogenous duodenal bile acid exposure and a different bile acid composition. In
      addition, it will be tested whether duodenal mucosal permeability of FD patients with an
      endogenous duodenal bile acid exposure above the normal range and an altered bile acid
      composition is higher than in FD patients with a normal endogenous duodenal acid exposure and
      composition.

      Participants will be expected on the department endoscopy of the UZ Gasthuisberg after they
      have fasted overnight. Before the study, 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.

      Gastroduodenoscopy will be performed by an experienced endoscopist (Jan Tack). Hereby, 12
      duodenal biopsies (2 biopsies at a time) (Radial Jaw™3 with needle; outside diameter 2.2mm;
      Boston Scientific, 302 Parkway, Global Park, Heredia, Costa Rica) will be obtained. To
      measure the in vitro transepithelial resistance, 4 biopsies will be examined using an adapted
      mini-Ussing chambers system. After equilibration, the mucosal side of the tissue will be
      exposed to 4kDa FITC-dextran as a measure of paracellular permeability. A sample will be
      taken from the serosal side during 2h at 30min interval. The concentration of fluorescein
      will then be measured using a fluorescence plate reader. Also, 2 biopsies will be used for
      mRNA extraction and subsequent cDNA synthesis. This cDNA will be used to measure the gene
      expression of cell-to-cell adhesion proteins and acid-sensing receptors by means of real-time
      PCR. In addition, 2 biopsies will be prepared for immunofluorescence and immunohistochemistry
      and 2 will be used for western blot to measure changes in distribution/expression of the
      cell-to-cell adhesion proteins and of bile acid-sensitive receptors. Two biopsies will be
      obtained to study ultrastructural alterations by transmission electron microscopy.

      After recovery, a catheter will be introduced in the second duodenum via the nose and the
      position of the catheter will be checked fluoroscopically. This catheter allows collection of
      intestinal fluids by means of a syringe to collect duodenal fluid aspirates and
      characterization of the bile acid composition of those samples (8). After 30 minutes, the
      participants will be given a specified amount of water (250 mL) (fasted state) and another 30
      minutes later a nutritional drink (fed state). Intestinal fluids will be sampled every 15 min
      for a period of 1 h before the liquid meal intake and until 90 minutes after the liquid meal
      intake. So, after the total collection period, 7 fractions for the fed state and 4 fractions
      for the fasted state will be obtained per participant in a time frame of 2 hours and a half.
      The composition of bile acids of the intestinal samples will be determined by GC-MS-selected
      ion monitoring analysis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Duodenal mucosal transepithelial electrical resistance (Ohm*cm^2)
time frame: 2 hours
description: Measurement for mucosal integrity
measure: Duodenal paracellular passage of Fitc Dextran 4 kDa (pmol)
time frame: 2 hours
description: Measurement for mucosal integrity
measure: Glycocholic acid concentration (mM)
time frame: 2.5 hours
description: Bile salt
measure: Taurocholic acid concentration (mM)
time frame: 2.5 hours
description: Bile salt
measure: Glycochenodeoxycholic acid concentration (mM)
time frame: 2.5 hours
description: Bile salt
measure: Taurochenodeoxycholic acid concentration (mM)
time frame: 2.5 hours
description: Bile salt
measure: Glycodeoxycholic acid concentration (mM)
time frame: 2.5 hours
description: Bile salt
measure: Taurodeoxycholic acid concentration (mM)
time frame: 2.5 hours
description: Bile salt
measure: Glycoursodeoxycholic acid concentration (mM)
time frame: 2.5 hours
description: Bile salt
measure: Tauroursodeoxycholic acid concentration (mM)
time frame: 2.5 hours
description: Bile salt
measure: Duodenal mucosal mastcell count (number of mastcells/mm^2 lamina propria)
time frame: 2 years
measure: Duodenal mucosal eosinophil count (number of eosinophils/mm^2 lamina propria)
time frame: 2 years
measure: RNA expression of Vitamin D receptor (VDR)
time frame: 2 years
description: Real-time RT-PCR
measure: RNA expression of bile acid receptor FXR
time frame: 2 years
description: Real-time RT-PCR
measure: RNA expression of bile acid receptor PXR
time frame: 2 years
description: Real-time RT-PCR
measure: RNA expression of bile acid receptor TGR5
time frame: 2 years
description: Real-time RT-PCR
measure: RNA expression of bile acid receptor CAR
time frame: 2 years
description: Real-time RT-PCR
measure: Protein expression of bile acid receptor VDR
time frame: 2 years
description: Western blot
measure: Protein expression of bile acid receptor FXR
time frame: 2 years
description: Western blot
measure: Protein expression of bile acid receptor PXR
time frame: 2 years
description: Western blot
measure: Protein expression of bile acid receptor TGR5
time frame: 2 years
description: Western blot
measure: Protein expression of bile acid receptor CAR
time frame: 2 years
description: Western blot
measure: Stomach complaints questionnaire
time frame: 2 years
description: Questions about stomach complaints
measure: ReQuest Questionnaire
time frame: 2 years
description: Reflux evaluation
measure: Council of Nutrition appetite questionnaire
time frame: 2 years
description: Questions about appetite
measure: Bowel complaints questionnaire
time frame: 2 years
description: Questions about bowel complaints
measure: Patient health questionnaire
time frame: 2 years
description: Questions about health
measure: Anxiety sensitivity index
time frame: 2 years
description: Questions about anxiety sensitivity
measure: Visceral sensitivity index
time frame: 2 years
description: Questions about visceral sensitivity
arm group label: Duodenal fluid aspiration
arm group type: Other
intervention type: Procedure
intervention name: Duodenogastroscopy
description: Catheter goes through the mouth in the duodenum to take duodenal biopsies.
arm group label: Duodenal fluid aspiration
intervention type: Device
intervention name: Duodenal aspiration catheter
description: Catheter goes through the nose in the duodenum to aspirate duodenal fluid in fasted and fed state.
arm group label: Duodenal fluid aspiration
intervention type: Dietary Supplement
intervention name: Nutri drink
description: Liquid meal of 200 ml.
arm group label: Duodenal fluid aspiration
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Dyspepsia
sharing ipd: No