<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/NCT02199002</url>
  </required_header>
  <id_info>
    <org_study_id>S55731</org_study_id>
    <nct_id>NCT02199002</nct_id>
  </id_info>
  <brief_title>Acid Pocket: Position and Aspiration</brief_title>
  <official_title>Acid Pocket: Different Position and Chemical Content Between Healthy Volunteers and GERD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gastroesophageal reflux disease (GERD) is a very common condition affecting up to 30% of&#xD;
      adults. To date, therapy consists of powerful acid suppression with proton pump inhibitors&#xD;
      (PPI). Nevertheless, only 60-70% of GERD patients report complete symptom relief with this&#xD;
      therapy. As the mechanisms underlying symptom perception in PPI resistant patients are not&#xD;
      fully understood, there is currently no adequate therapy available.&#xD;
&#xD;
      It is becoming increasingly clear that reflux, especially in the postprandial period, occurs&#xD;
      from a reservoir of acid floating on top of the meal: the so-called &quot;acid pocket&quot;. In this&#xD;
      study, we aim to investigate further the acid pocket by determining its exact position and&#xD;
      chemical contents between healthy volunteers, GERD patient who respond well and bad to PPI&#xD;
      therapy and GERD patients with barrett's esophagus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A costume made multi-pH-impedance manometry catheter will be placed in the esophagus and&#xD;
      clipped to the Z-line. Patients then will be given a standardized meal and the position of&#xD;
      the acid pocket will be measured. After two hours the pocket will be aspirated through a&#xD;
      gastric catheter. Then, patients will be allowed to return home and the study will be&#xD;
      continued for another 22 hours.&#xD;
&#xD;
      The special catheter will be removed at the end of the study. Collected acid pockets will be&#xD;
      used to analyze content and perform permeability experiments.&#xD;
&#xD;
      Data of the 24-hour experiment will be used to evaluate the position of the acid pocket and&#xD;
      number of reflux episodes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</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>acid pocket position</measure>
    <time_frame>participants will be followed for 24 hours</time_frame>
    <description>Acid position will be determined relatively to the lower esophageal sfincter. Differences in position between healthy volunteers, PPI responders, PPI non-responders and patients with barrett esophagus will be evaluated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of reflux episodes</measure>
    <time_frame>24 hours</time_frame>
    <description>number of reflux episodes will be counted and compared between the different groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>acid pocket contents</measure>
    <time_frame>1 year</time_frame>
    <description>after collection of all acid pocket, pockets will be processed to determine it's exact chemical content.</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>GERD - PPI Responders</condition>
  <condition>GERD - PPI Non-responders</condition>
  <condition>Barrett Esophagus</condition>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>healthy volunteers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>healthy volunteers (no gastric complains)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PPI responders</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>proven reflux, good symptom relief upon PPI therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PPI non-responders</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>proven reflux disease, poor symptom control (less then 50% symptom reduction) upon PPI therapy (2x40mg omeprazole)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Barrett - no dysplasia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>proven barrett with no dysplasia on biopsies</description>
  </arm_group>
  <arm_group>
    <arm_group_label>barrett - high grade dysplasia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>proven barrett with high grade dysplasia on biopsies</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>multi-pH-impedance manometry catheter</intervention_name>
    <description>a special catheter will be placed in the esophagus of all study groups. Measurment of pH, impedance and pressure will be performed.</description>
    <arm_group_label>Barrett - no dysplasia</arm_group_label>
    <arm_group_label>PPI non-responders</arm_group_label>
    <arm_group_label>PPI responders</arm_group_label>
    <arm_group_label>barrett - high grade dysplasia</arm_group_label>
    <arm_group_label>healthy volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
          -  older than 18 years&#xD;
&#xD;
          -  fit to criteria of 'study population' (HV, PPI responder, PPI non-responder, Barrett)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#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>Guy Boeckxstaens, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Catholic University Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Catholic University Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Guy Boeckxstaens</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>acid pocket</keyword>
  <keyword>GERD</keyword>
  <keyword>Barrett</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Barrett Esophagus</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/NCT02199002
org study id: S55731
nct id: NCT02199002
lead sponsor: 
has dmc: No
Gastroesophageal reflux disease (GERD) is a very common condition affecting up to 30% of
      adults. To date, therapy consists of powerful acid suppression with proton pump inhibitors
      (PPI). Nevertheless, only 60-70% of GERD patients report complete symptom relief with this
      therapy. As the mechanisms underlying symptom perception in PPI resistant patients are not
      fully understood, there is currently no adequate therapy available.

      It is becoming increasingly clear that reflux, especially in the postprandial period, occurs
      from a reservoir of acid floating on top of the meal: the so-called "acid pocket". In this
      study, we aim to investigate further the acid pocket by determining its exact position and
      chemical contents between healthy volunteers, GERD patient who respond well and bad to PPI
      therapy and GERD patients with barrett's esophagus.
A costume made multi-pH-impedance manometry catheter will be placed in the esophagus and
      clipped to the Z-line. Patients then will be given a standardized meal and the position of
      the acid pocket will be measured. After two hours the pocket will be aspirated through a
      gastric catheter. Then, patients will be allowed to return home and the study will be
      continued for another 22 hours.

      The special catheter will be removed at the end of the study. Collected acid pockets will be
      used to analyze content and perform permeability experiments.

      Data of the 24-hour experiment will be used to evaluate the position of the acid pocket and
      number of reflux episodes.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: acid pocket position
time frame: participants will be followed for 24 hours
description: Acid position will be determined relatively to the lower esophageal sfincter. Differences in position between healthy volunteers, PPI responders, PPI non-responders and patients with barrett esophagus will be evaluated
measure: number of reflux episodes
time frame: 24 hours
description: number of reflux episodes will be counted and compared between the different groups.
measure: acid pocket contents
time frame: 1 year
description: after collection of all acid pocket, pockets will be processed to determine it's exact chemical content.
arm group label: healthy volunteers
arm group type: Other
description: healthy volunteers (no gastric complains)
arm group label: PPI responders
arm group type: Other
description: proven reflux, good symptom relief upon PPI therapy
arm group label: PPI non-responders
arm group type: Other
description: proven reflux disease, poor symptom control (less then 50% symptom reduction) upon PPI therapy (2x40mg omeprazole)
arm group label: Barrett - no dysplasia
arm group type: Other
description: proven barrett with no dysplasia on biopsies
arm group label: barrett - high grade dysplasia
arm group type: Other
description: proven barrett with high grade dysplasia on biopsies
intervention type: Device
intervention name: multi-pH-impedance manometry catheter
description: a special catheter will be placed in the esophagus of all study groups. Measurment of pH, impedance and pressure will be performed.
arm group label: Barrett - no dysplasia
arm group label: PPI non-responders
arm group label: PPI responders
arm group label: barrett - high grade dysplasia
arm group label: healthy volunteers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Guy Boeckxstaens, MD, PhD
role: Principal Investigator
affiliation: Catholic University Leuven
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Guy Boeckxstaens
investigator title: MD, PhD
mesh term: Barrett Esophagus