<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/NCT01692613</url>
  </required_header>
  <id_info>
    <org_study_id>A139/12</org_study_id>
    <nct_id>NCT01692613</nct_id>
  </id_info>
  <brief_title>Endomicroscopy, IBS and Food Intolerance</brief_title>
  <official_title>Confocal Endomicrosopy for the Detection of Food Intolerance in Patients With Irritable Bowel Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Schleswig-Holstein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Great Ormond Street Hospital for Children NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johannes Gutenberg University Mainz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Schleswig-Holstein</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      The immediate endoscopic identification and diagnosis of intraepithelial structures and&#xD;
      immediate and delayed reactions to allergens in the mucosal surface of the gut are unmet&#xD;
      goals in the diagnosis and management of subjects with food intolerances, who are negative to&#xD;
      all available tests. Endomicroscopy may be helpful to further visualize and characterize&#xD;
      unmasked small bowel reactions to foods, which has not been described before.&#xD;
&#xD;
      Confocal laser endomicroscopy provides confocal microscopic imaging simultaneously to the&#xD;
      macroscopic view ,which enables the examiner to see immediate reactions after exposure and it&#xD;
      further allows capturing of fluid excreted by the gut for further analysis to understand the&#xD;
      pathology behind this reaction further.&#xD;
&#xD;
      N=50 patients with unexplained bloating and diarrhoea with suspicion of food intolerance and&#xD;
      negative testing with routine methods. Patients with Lactose intolerance n=10 patients to&#xD;
      compare results. Patients with Fructose intolerance n=10 patients to compare results.&#xD;
      Volunteers with Barrett's esophagus who need evaluation for possible dysplasia in the&#xD;
      Barrett's mucosa with confocal endomicrosopy but no symptoms of bloating and abdominal pain&#xD;
      (n=10) to serve as healthy controls for allergy testing.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      The primary objective is to investigate whether endomicroscopy will allow the detection of an&#xD;
      allergic reaction of the gut after exposure of the 5 major allergens in the following way:&#xD;
&#xD;
      After standard gastroscopy with the endomicroscope including evaluation of the surface of the&#xD;
      upper gastrointestinal tract, i.v. injection of Fluorescein, then initial visualisation of&#xD;
      the duodenal surface including count of initial lymphocytes/mononuclear cells in the lamina&#xD;
      propria: Allergen 1 (milk), allergen 2 (wheat), allergen 3 (soya),allergen 4 (apple),&#xD;
      allergen 5 (yeast).&#xD;
&#xD;
      The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in&#xD;
      the lamina propria of the duodenum, representing an acute reaction to one of the allergens&#xD;
      sprayed to its surface through the endoscope channel.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in&#xD;
      the lamina propria of the duodenum, representing an acute reaction to one of the allergens&#xD;
      sprayed to its surface through the endoscope channel.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of mucosal reaction</measure>
    <time_frame>immediate</time_frame>
  </primary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Endomicroscopy</condition>
  <condition>Inflammatory Bowel Syndrome</condition>
  <condition>Food Intolerance</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  duodenal biopsies&#xD;
&#xD;
        -  duodenal fluid&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        -  N=50 patients with unexplained bloating and diarrhoea with suspicion of food&#xD;
             intolerance and negative testing with routine methods&#xD;
&#xD;
          -  N=10 patients with Lactose intolerance&#xD;
&#xD;
          -  N=10 patients with Fructose intolerance&#xD;
&#xD;
          -  N=10 volunteers with Barrett's esophagus who need evaluation for possible dysplasia in&#xD;
             the Barrett's mucosa with confocal endomicrosopy but no symptoms of bloating and&#xD;
             abdominal pain (n=10) to serve as healthy controls for allergy testing&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  ongoing abdominal symptoms such as bloating and abdominal pain&#xD;
&#xD;
          -  negative routine testing for food intolerance (or known lactose/fructose intolerance)&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no consent&#xD;
&#xD;
          -  known reason for the abdominal pain and bloating other than lactose/fructose&#xD;
             intolerance&#xD;
&#xD;
          -  M. Whipple&#xD;
&#xD;
          -  known infectious gastrointestinal disease&#xD;
&#xD;
          -  stricture in the upper gastrointestinal tract&#xD;
&#xD;
          -  age &gt;18years&#xD;
&#xD;
          -  impaired renal function (Creatinine &gt;1.2 mg/dL)&#xD;
&#xD;
          -  pregnancy or breast feeding&#xD;
&#xD;
          -  inability to obtain informed consent&#xD;
&#xD;
          -  active GI Bleeding&#xD;
&#xD;
          -  known allergy to Methylene blue or Fluorescein&#xD;
&#xD;
          -  participation in other clinical trials within the last 4 weeks&#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>Annette Fritscher-Ravens, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Schleswig-Holstein</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Schleswig Holstein, Campus Kiel, Unit Experimental Endoscopy</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>June 2, 2015</last_update_submitted>
  <last_update_submitted_qc>June 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Schleswig-Holstein</investigator_affiliation>
    <investigator_full_name>Mark Ellrichmann</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Food Intolerance</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/NCT01692613
org study id: A139/12
nct id: NCT01692613
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Background:

      The immediate endoscopic identification and diagnosis of intraepithelial structures and
      immediate and delayed reactions to allergens in the mucosal surface of the gut are unmet
      goals in the diagnosis and management of subjects with food intolerances, who are negative to
      all available tests. Endomicroscopy may be helpful to further visualize and characterize
      unmasked small bowel reactions to foods, which has not been described before.

      Confocal laser endomicroscopy provides confocal microscopic imaging simultaneously to the
      macroscopic view ,which enables the examiner to see immediate reactions after exposure and it
      further allows capturing of fluid excreted by the gut for further analysis to understand the
      pathology behind this reaction further.

      N=50 patients with unexplained bloating and diarrhoea with suspicion of food intolerance and
      negative testing with routine methods. Patients with Lactose intolerance n=10 patients to
      compare results. Patients with Fructose intolerance n=10 patients to compare results.
      Volunteers with Barrett's esophagus who need evaluation for possible dysplasia in the
      Barrett's mucosa with confocal endomicrosopy but no symptoms of bloating and abdominal pain
      (n=10) to serve as healthy controls for allergy testing.

      Methods:

      The primary objective is to investigate whether endomicroscopy will allow the detection of an
      allergic reaction of the gut after exposure of the 5 major allergens in the following way:

      After standard gastroscopy with the endomicroscope including evaluation of the surface of the
      upper gastrointestinal tract, i.v. injection of Fluorescein, then initial visualisation of
      the duodenal surface including count of initial lymphocytes/mononuclear cells in the lamina
      propria: Allergen 1 (milk), allergen 2 (wheat), allergen 3 (soya),allergen 4 (apple),
      allergen 5 (yeast).

      The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in
      the lamina propria of the duodenum, representing an acute reaction to one of the allergens
      sprayed to its surface through the endoscope channel.
The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in
      the lamina propria of the duodenum, representing an acute reaction to one of the allergens
      sprayed to its surface through the endoscope channel.
observational model: Case-Control
time perspective: Prospective
measure: Number of mucosal reaction
time frame: immediate
-  duodenal biopsies

        -  duodenal fluid
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Annette Fritscher-Ravens, Prof. Dr.
role: Principal Investigator
affiliation: University Schleswig-Holstein
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Schleswig-Holstein
investigator full name: Mark Ellrichmann
investigator title: Dr.
mesh term: Syndrome
mesh term: Food Intolerance