<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/NCT03834298</url>
  </required_header>
  <id_info>
    <org_study_id>19-0018</org_study_id>
    <nct_id>NCT03834298</nct_id>
  </id_info>
  <brief_title>Non-endoscopic Tracking of Disease Activity in Eosinophilic Esophagitis</brief_title>
  <official_title>Non-endoscopic Tracking of Disease Activity During Dietary Interventions in Eosinophilic Esophagitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ann &amp; Robert H Lurie Children's Hospital of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To prospectively determine the natural history of inflammation resolution following&#xD;
      initiation of diet treatment and to optimize the diet treatment of patients with EoE through&#xD;
      the use of a non-endoscopic tracking device, the esophageal string test (EST).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an adult and pediatric prospective, longitudinal study in which we will measure&#xD;
      symptoms, QOL and inflammation at baseline and again at 2, 4 and 6 weeks after starting stand&#xD;
      of care (SOC) four food elimination diet (FFED) (Aim 1). Newly or previously diagnosed&#xD;
      patients with EoE with active disease who will be undergoing SOC FFED will be offered entry&#xD;
      into the study by the PI's or their local co-investigators at each of their institutions. EoE&#xD;
      patients who are in remission on SOC FFED from Aim 1 will be recruited to participate in this&#xD;
      food reintroduction trial in Aim 2. Eligible subjects will undergo SOC sequential food&#xD;
      reintroductions and during the food introduction, ESTs will be performed at 2 and 4 week&#xD;
      intervals during a clinic visit. If inflammation is detected by the EST, this food will be&#xD;
      eliminated from the diet for six weeks and a repeat EST will be administered at this time to&#xD;
      assess inflammation. If inflammation has resolved based on EST results, food reintroduction&#xD;
      will resume. If no inflammation is detected by the EST at the 4 week interval, a new food&#xD;
      will be added. EST will be performed after each food reintroduction as outlined above. Based&#xD;
      on known allergenic properties of these foods, the order of food reintroduction will be soy,&#xD;
      eggs, wheat and milk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study grant not obtained; not moving forward with study at this time.&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 1, 2021</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2023</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>Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Disease remission will be an EoEScore &lt;0.36, the score below which the patient has a very low probability of having an eosinophil count &gt; 15 eos/HPF = active EoE. This decision rule is associated with a sensitivity of 0.92 and specificity of 0.28 for having active EoE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)</measure>
    <time_frame>2 weeks</time_frame>
    <description>Disease remission will be an EoEScore &lt;0.36, the score below which the patient has a very low probability of having an eosinophil count &gt; 15 eos/HPF = active EoE. This decision rule is associated with a sensitivity of 0.92 and specificity of 0.28 for having active EoE. This 2 week time point will be a co-primary outcome measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Disease remission will be an EoEScore &lt;0.36, the score below which the patient has a very low probability of having an eosinophil count &gt; 15 eos/HPF = active EoE. This decision rule is associated with a sensitivity of 0.92 and specificity of 0.28 for having active EoE. This 4 week time point will be a co-primary outcome measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Symptom Severity in Participants Age 18-65 as Measured by Eosinophilic Esophagitis Activity Index (EESAI)</measure>
    <time_frame>Baseline and 6 weeks</time_frame>
    <description>The validated symptoms severity assessment tool Eosinophilic Esophagitis Activity Index (EESAI) will be used to assess severity in participants age 18 to 65.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Symptom Severity in Participants Age 7-18 as Measured by Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS v 2.)</measure>
    <time_frame>Baseline and 6 weeks</time_frame>
    <description>The validated symptoms severity assessment tool Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS v 2.) will be used to assess severity in participants age 7 to 18.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Disease Recurrence as Measured by EST score</measure>
    <time_frame>4 weeks after food re-introduction</time_frame>
    <description>To determine the time to disease recurrence with re-introduction of potential food allergen triggers, disease recurrence will be indicated by an EoEScore probability of &gt; 0.53.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Disease Recurrence as Measured by EST score</measure>
    <time_frame>2 weeks after food re-introduction</time_frame>
    <description>To determine the time to disease recurrence with re-introduction of potential food allergen triggers, disease recurrence will be indicated by an EoEScore probability of &gt; 0.53.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Eosinophilic Esophagitis</condition>
  <arm_group>
    <arm_group_label>Four Food Elimination Diet (FFED)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There is one arm to the study. All participants meeting eligibility will be assigned to intervention / treatment with a previously defined four food elimination diet (FFED) (Aim 1). This is a longitudinal study in which outcome measures including symptoms, QOL and inflammation at baseline and at 2, 4 and 6 weeks after starting stand of care (SOC) FFED will be measured. Participants meeting eligibility for Aim 2 will have foods added back to the diet using a specified protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Four Food Elimination Diet</intervention_name>
    <description>Food allergens are thought to initiate eosinophilic inflammation and dietary elimination of trigger allergens is an effective treatment for EoE. Previous work demonstrates that in both children and adult EoE patients, the food antigens including cow's milk, wheat, egg, soy, peanut/tree nut and fish/shell fish, are the most common food triggers causing esophageal inflammation. Participants will be assigned to single arm treatment / intervention with a diet restricted of the four most common food allergens, milk, soy, wheat and egg, or a four food elimination diet (FFED). With the goal to optimize diet treatment, in Aim 2, eligible participants will undergo sequential food reintroductions based on protocol.</description>
    <arm_group_label>Four Food Elimination Diet (FFED)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant must be able to understand and provide informed consent&#xD;
&#xD;
          -  Males and Females ≥7 years of age to 65 years of age&#xD;
&#xD;
          -  Have diagnosis of EoE&#xD;
&#xD;
          -  Have histologically confirmed active disease ≥15 eosinophils/hpf&#xD;
&#xD;
          -  Symptomatic (have experienced symptoms within the last one months prior to&#xD;
             enrollment).&#xD;
&#xD;
          -  Female subjects of childbearing potential must have a negative pregnancy test upon&#xD;
             study entry&#xD;
&#xD;
          -  Female (and male) subjects with reproductive potential, must agree to use FDA approved&#xD;
             methods of birth control for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability or unwillingness of a participant to give written informed consent or comply&#xD;
             with study protocol&#xD;
&#xD;
          -  Secondary causes of eosinophilia&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Immunodeficiency states&#xD;
&#xD;
          -  Have participated in any investigative drug study within 6 weeks prior to study entry&#xD;
&#xD;
          -  Unable to complete study procedures including endoscopy&#xD;
&#xD;
          -  Luminal stricture identified &lt;13mm which would prevent passage of the EST and prevent&#xD;
             assessment of mucosal inflammation&#xD;
&#xD;
          -  Past or current medical problems or findings from physical examination or laboratory&#xD;
             testing that are not listed above, which, in the opinion of the investigator, may pose&#xD;
             additional risks from participation in the study, may interfere with the participant's&#xD;
             ability to comply with study requirements or that may impact the quality or&#xD;
             interpretation of the data obtained from the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Calies Menard-Katcher, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2023</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/NCT03834298
org study id: 19-0018
nct id: NCT03834298
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To prospectively determine the natural history of inflammation resolution following
      initiation of diet treatment and to optimize the diet treatment of patients with EoE through
      the use of a non-endoscopic tracking device, the esophageal string test (EST).
This is an adult and pediatric prospective, longitudinal study in which we will measure
      symptoms, QOL and inflammation at baseline and again at 2, 4 and 6 weeks after starting stand
      of care (SOC) four food elimination diet (FFED) (Aim 1). Newly or previously diagnosed
      patients with EoE with active disease who will be undergoing SOC FFED will be offered entry
      into the study by the PI's or their local co-investigators at each of their institutions. EoE
      patients who are in remission on SOC FFED from Aim 1 will be recruited to participate in this
      food reintroduction trial in Aim 2. Eligible subjects will undergo SOC sequential food
      reintroductions and during the food introduction, ESTs will be performed at 2 and 4 week
      intervals during a clinic visit. If inflammation is detected by the EST, this food will be
      eliminated from the diet for six weeks and a repeat EST will be administered at this time to
      assess inflammation. If inflammation has resolved based on EST results, food reintroduction
      will resume. If no inflammation is detected by the EST at the 4 week interval, a new food
      will be added. EST will be performed after each food reintroduction as outlined above. Based
      on known allergenic properties of these foods, the order of food reintroduction will be soy,
      eggs, wheat and milk.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
time frame: 6 weeks
description: Disease remission will be an EoEScore <0.36, the score below which the patient has a very low probability of having an eosinophil count > 15 eos/HPF = active EoE. This decision rule is associated with a sensitivity of 0.92 and specificity of 0.28 for having active EoE.
measure: Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
time frame: 2 weeks
description: Disease remission will be an EoEScore <0.36, the score below which the patient has a very low probability of having an eosinophil count > 15 eos/HPF = active EoE. This decision rule is associated with a sensitivity of 0.92 and specificity of 0.28 for having active EoE. This 2 week time point will be a co-primary outcome measure.
measure: Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
time frame: 4 weeks
description: Disease remission will be an EoEScore <0.36, the score below which the patient has a very low probability of having an eosinophil count > 15 eos/HPF = active EoE. This decision rule is associated with a sensitivity of 0.92 and specificity of 0.28 for having active EoE. This 4 week time point will be a co-primary outcome measure.
measure: Change in Symptom Severity in Participants Age 18-65 as Measured by Eosinophilic Esophagitis Activity Index (EESAI)
time frame: Baseline and 6 weeks
description: The validated symptoms severity assessment tool Eosinophilic Esophagitis Activity Index (EESAI) will be used to assess severity in participants age 18 to 65.
measure: Change in Symptom Severity in Participants Age 7-18 as Measured by Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS v 2.)
time frame: Baseline and 6 weeks
description: The validated symptoms severity assessment tool Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS v 2.) will be used to assess severity in participants age 7 to 18.
measure: Time to Disease Recurrence as Measured by EST score
time frame: 4 weeks after food re-introduction
description: To determine the time to disease recurrence with re-introduction of potential food allergen triggers, disease recurrence will be indicated by an EoEScore probability of > 0.53.
measure: Time to Disease Recurrence as Measured by EST score
time frame: 2 weeks after food re-introduction
description: To determine the time to disease recurrence with re-introduction of potential food allergen triggers, disease recurrence will be indicated by an EoEScore probability of > 0.53.
arm group label: Four Food Elimination Diet (FFED)
arm group type: Experimental
description: There is one arm to the study. All participants meeting eligibility will be assigned to intervention / treatment with a previously defined four food elimination diet (FFED) (Aim 1). This is a longitudinal study in which outcome measures including symptoms, QOL and inflammation at baseline and at 2, 4 and 6 weeks after starting stand of care (SOC) FFED will be measured. Participants meeting eligibility for Aim 2 will have foods added back to the diet using a specified protocol.
intervention type: Other
intervention name: Four Food Elimination Diet
description: Food allergens are thought to initiate eosinophilic inflammation and dietary elimination of trigger allergens is an effective treatment for EoE. Previous work demonstrates that in both children and adult EoE patients, the food antigens including cow's milk, wheat, egg, soy, peanut/tree nut and fish/shell fish, are the most common food triggers causing esophageal inflammation. Participants will be assigned to single arm treatment / intervention with a diet restricted of the four most common food allergens, milk, soy, wheat and egg, or a four food elimination diet (FFED). With the goal to optimize diet treatment, in Aim 2, eligible participants will undergo sequential food reintroductions based on protocol.
arm group label: Four Food Elimination Diet (FFED)
criteria: 
gender: All
minimum age: 7 Years
maximum age: 65 Years
healthy volunteers: No
last name: Calies Menard-Katcher, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
responsible party type: Sponsor
mesh term: Esophagitis
mesh term: Eosinophilic Esophagitis
sharing ipd: No