<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/NCT03803527</url>
  </required_header>
  <id_info>
    <org_study_id>19-0074</org_study_id>
    <nct_id>NCT03803527</nct_id>
  </id_info>
  <brief_title>Metabolomic Profiling of Eosinophilic Esophagitis</brief_title>
  <official_title>Metabolomic Profiling of Eosinophilic Esophagitis Patients With Dysphagia for Biomarker Discovery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective longitudinal, observational study of adolescent and adults that will identify&#xD;
      novel metabolites associated with dysphagia in Eosinophilic Esophagitis (EoE).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the investigators seek to understand whether a metabolomic profile obtained&#xD;
      from esophageal samples correlate with the symptom of dysphagia in adolescent and adults. The&#xD;
      investigators hypothesize that intraluminal secreted metabolite(s) will change during&#xD;
      episodes of dysphagia. The aim of the study will be to use a novel method of producing&#xD;
      esophageal luminal samples, the esophageal string test, to capture esophageal metabolites&#xD;
      when a patient is and is not experiencing dysphagia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    This study did not receive the grant that was applied for to conduct the study.&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 1, 2019</start_date>
  <completion_date type="Anticipated">August 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2021</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brief Esophageal Dysphagia Questionnaire</measure>
    <time_frame>Time of Endoscopic Procedure</time_frame>
    <description>Positive Dysphagia symptoms Measured by Brief Esophageal Dysphagia Questionnaire. The questionnaire asks questions about dysphagia symptoms and the scale is from 0 (rarely/never) to 5 (several times per day).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Eosinophilic Esophagitis</condition>
  <arm_group>
    <arm_group_label>EST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects enrolled into the study will:&#xD;
Complete a clinical history&#xD;
Have vitals obtained&#xD;
Complete Patient-reported outcomes&#xD;
Have Esophageal mucosal biopsies collected as part of standard of care at the time of the most recent endoscopy to report the peak eosinophilia per hpf.&#xD;
Complete the Esophageal String test</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Esophageal String Test</intervention_name>
    <description>An EST will be performed for a 1hour sampling period on the same day as the scheduled clinic visit. Subjects will be asked to swallow a capsule and the attached EST string will be taped to the cheek with tegaderm tape. At the completion of the 1-hour sampling period, the EST will be removed and it will immediately be processed and cryopreserved for metabolomics profiling.</description>
    <arm_group_label>EST</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with Eosinophilic Esophagitis (EoE) and seen either at Children's Hospital&#xD;
             Colorado or University of Colorado Hospital for scheduled outpatient clinical&#xD;
             assessment or upper GI endoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute food impaction at time of study&#xD;
&#xD;
          -  Recent (within 2 months) use of systemic steroids&#xD;
&#xD;
          -  Other known esophageal disease or esophageal injury (e.g. tracheoesophageal fistula,&#xD;
             congenital stricture, caustic injury)&#xD;
&#xD;
          -  known other inflammatory bowel disease&#xD;
&#xD;
          -  inability to swallow the EST&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>October 14, 2019</last_update_submitted>
  <last_update_submitted_qc>October 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2019</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>Esophagitis</mesh_term>
    <mesh_term>Eosinophilic Esophagitis</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/NCT03803527
org study id: 19-0074
nct id: NCT03803527
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A prospective longitudinal, observational study of adolescent and adults that will identify
      novel metabolites associated with dysphagia in Eosinophilic Esophagitis (EoE).
In this study, the investigators seek to understand whether a metabolomic profile obtained
      from esophageal samples correlate with the symptom of dysphagia in adolescent and adults. The
      investigators hypothesize that intraluminal secreted metabolite(s) will change during
      episodes of dysphagia. The aim of the study will be to use a novel method of producing
      esophageal luminal samples, the esophageal string test, to capture esophageal metabolites
      when a patient is and is not experiencing dysphagia.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Brief Esophageal Dysphagia Questionnaire
time frame: Time of Endoscopic Procedure
description: Positive Dysphagia symptoms Measured by Brief Esophageal Dysphagia Questionnaire. The questionnaire asks questions about dysphagia symptoms and the scale is from 0 (rarely/never) to 5 (several times per day).
arm group label: EST
arm group type: Experimental
description: All subjects enrolled into the study will:
Complete a clinical history
Have vitals obtained
Complete Patient-reported outcomes
Have Esophageal mucosal biopsies collected as part of standard of care at the time of the most recent endoscopy to report the peak eosinophilia per hpf.
Complete the Esophageal String test
intervention type: Procedure
intervention name: Esophageal String Test
description: An EST will be performed for a 1hour sampling period on the same day as the scheduled clinic visit. Subjects will be asked to swallow a capsule and the attached EST string will be taped to the cheek with tegaderm tape. At the completion of the 1-hour sampling period, the EST will be removed and it will immediately be processed and cryopreserved for metabolomics profiling.
arm group label: EST
criteria: 
gender: All
minimum age: 11 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Esophagitis
mesh term: Eosinophilic Esophagitis
sharing ipd: No