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Non-endoscopic Tracking of Disease Activity in Eosinophilic Esophagitis

Primary Purpose

Eosinophilic Esophagitis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Four Food Elimination Diet
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Eosinophilic Esophagitis

Eligibility Criteria

7 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant must be able to understand and provide informed consent
  • Males and Females ≥7 years of age to 65 years of age
  • Have diagnosis of EoE
  • Have histologically confirmed active disease ≥15 eosinophils/hpf
  • Symptomatic (have experienced symptoms within the last one months prior to enrollment).
  • Female subjects of childbearing potential must have a negative pregnancy test upon study entry
  • Female (and male) subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study

Exclusion Criteria:

  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  • Secondary causes of eosinophilia
  • Pregnancy
  • Immunodeficiency states
  • Have participated in any investigative drug study within 6 weeks prior to study entry
  • Unable to complete study procedures including endoscopy
  • Luminal stricture identified <13mm which would prevent passage of the EST and prevent assessment of mucosal inflammation
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Four Food Elimination Diet (FFED)

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
    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.
    Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
    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.
    Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
    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.

    Secondary Outcome Measures

    Change in Symptom Severity in Participants Age 18-65 as Measured by Eosinophilic Esophagitis Activity Index (EESAI)
    The validated symptoms severity assessment tool Eosinophilic Esophagitis Activity Index (EESAI) will be used to assess severity in participants age 18 to 65.
    Change in Symptom Severity in Participants Age 7-18 as Measured by Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS v 2.)
    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.
    Time to Disease Recurrence as Measured by EST score
    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.
    Time to Disease Recurrence as Measured by EST score
    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.

    Full Information

    First Posted
    January 4, 2019
    Last Updated
    March 28, 2023
    Sponsor
    University of Colorado, Denver
    Collaborators
    Northwestern University, Ann & Robert H Lurie Children's Hospital of Chicago
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03834298
    Brief Title
    Non-endoscopic Tracking of Disease Activity in Eosinophilic Esophagitis
    Official Title
    Non-endoscopic Tracking of Disease Activity During Dietary Interventions in Eosinophilic Esophagitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study grant not obtained; not moving forward with study at this time.
    Study Start Date
    June 1, 2021 (Anticipated)
    Primary Completion Date
    August 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver
    Collaborators
    Northwestern University, Ann & Robert H Lurie Children's Hospital of Chicago

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eosinophilic Esophagitis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Four Food Elimination Diet (FFED)
    Arm Type
    Experimental
    Arm 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(s)
    Four Food Elimination Diet
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
    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.
    Time Frame
    6 weeks
    Title
    Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
    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.
    Time Frame
    2 weeks
    Title
    Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
    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.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Change in Symptom Severity in Participants Age 18-65 as Measured by Eosinophilic Esophagitis Activity Index (EESAI)
    Description
    The validated symptoms severity assessment tool Eosinophilic Esophagitis Activity Index (EESAI) will be used to assess severity in participants age 18 to 65.
    Time Frame
    Baseline and 6 weeks
    Title
    Change in Symptom Severity in Participants Age 7-18 as Measured by Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS v 2.)
    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.
    Time Frame
    Baseline and 6 weeks
    Title
    Time to Disease Recurrence as Measured by EST score
    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.
    Time Frame
    4 weeks after food re-introduction
    Title
    Time to Disease Recurrence as Measured by EST score
    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.
    Time Frame
    2 weeks after food re-introduction

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participant must be able to understand and provide informed consent Males and Females ≥7 years of age to 65 years of age Have diagnosis of EoE Have histologically confirmed active disease ≥15 eosinophils/hpf Symptomatic (have experienced symptoms within the last one months prior to enrollment). Female subjects of childbearing potential must have a negative pregnancy test upon study entry Female (and male) subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study Exclusion Criteria: Inability or unwillingness of a participant to give written informed consent or comply with study protocol Secondary causes of eosinophilia Pregnancy Immunodeficiency states Have participated in any investigative drug study within 6 weeks prior to study entry Unable to complete study procedures including endoscopy Luminal stricture identified <13mm which would prevent passage of the EST and prevent assessment of mucosal inflammation Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Calies Menard-Katcher, MD
    Organizational Affiliation
    University of Colorado, Denver
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Non-endoscopic Tracking of Disease Activity in Eosinophilic Esophagitis

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