<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/NCT02190513</url>
  </required_header>
  <id_info>
    <org_study_id>SJ 0211-07</org_study_id>
    <nct_id>NCT02190513</nct_id>
  </id_info>
  <brief_title>Prevalence of Eosinophilic Esophagitis in Children With Celiac Disease</brief_title>
  <official_title>Prevalence of Eosinophilic Esophagitis in Children With Celiac Disease and Prevalence of Celiac Disease in Children With Eosinophilic Esophagitis in a Tertiary Community Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. John Health System, Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. John Health System, Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Celiac disease (CD) and eosinophilic esophagitis (EE) are distinct diseases of the&#xD;
      gastrointestinal tract with specific clinico-pathological characteristics. In recent years,&#xD;
      in the literature, several children who underwent upper gastrointestinal endoscopy for&#xD;
      suspected CD, which was confirmed histologically, were also found to have coexistent EE.&#xD;
      There are reports of coexistent CD and EE. We would like to see the prevalence of EE in&#xD;
      children with CD and the prevalence of CD in children with EE in our population, and to do so&#xD;
      would like to review medical records. Our objectives are to determine if children with celiac&#xD;
      disease have a high prevalence of eosinophilic esophagitis.and to determine if children with&#xD;
      eosinophilic esophagitis have increased risk of developing celiac disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <primary_completion_date type="Actual">June 2013</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Review of histopathology reports of esophageal biopsies to record the number of eosinophils per high power field.</measure>
    <time_frame>Retrospective chart review study, no contact made with patients, so no patient time is required, expected average of 2 years</time_frame>
  </primary_outcome>
  <enrollment type="Actual">56</enrollment>
  <condition>Celiac Disease</condition>
  <condition>Eosinophilic Esophagitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children seen in the Pediatric Gastroenterology clinic at St. John Hospital &amp; Medical&#xD;
        Center and diagnosed with celiac disease or eosinophilic esophagitis or both based on the&#xD;
        endoscopic and histopathological findings.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Seen in the Pediatric Gastroenterology clinic at St. John Hospital &amp; Medical Center&#xD;
             during study time frame&#xD;
&#xD;
          -  Age 2-21 years old&#xD;
&#xD;
          -  Diagnosed with CD or EE or both based on the endoscopic and histopathological findings&#xD;
             .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gastroesophageal reflux diagnosed by PH probe.&#xD;
&#xD;
          -  History of chemical ingestion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. John Health System, Michigan</investigator_affiliation>
    <investigator_full_name>Hernando Lyons, MD</investigator_full_name>
    <investigator_title>tSection Chief of Pediatric Gastroenterology at St. John Hospital and Medical Center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophagitis</mesh_term>
    <mesh_term>Celiac Disease</mesh_term>
    <mesh_term>Eosinophilic Esophagitis</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/NCT02190513
org study id: SJ 0211-07
nct id: NCT02190513
lead sponsor: 
has dmc: No
Celiac disease (CD) and eosinophilic esophagitis (EE) are distinct diseases of the
      gastrointestinal tract with specific clinico-pathological characteristics. In recent years,
      in the literature, several children who underwent upper gastrointestinal endoscopy for
      suspected CD, which was confirmed histologically, were also found to have coexistent EE.
      There are reports of coexistent CD and EE. We would like to see the prevalence of EE in
      children with CD and the prevalence of CD in children with EE in our population, and to do so
      would like to review medical records. Our objectives are to determine if children with celiac
      disease have a high prevalence of eosinophilic esophagitis.and to determine if children with
      eosinophilic esophagitis have increased risk of developing celiac disease.
observational model: Cohort
time perspective: Retrospective
measure: Review of histopathology reports of esophageal biopsies to record the number of eosinophils per high power field.
time frame: Retrospective chart review study, no contact made with patients, so no patient time is required, expected average of 2 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 21 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: St. John Health System, Michigan
investigator full name: Hernando Lyons, MD
investigator title: tSection Chief of Pediatric Gastroenterology at St. John Hospital and Medical Center
mesh term: Esophagitis
mesh term: Celiac Disease
mesh term: Eosinophilic Esophagitis