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Withdrawn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
About this trial
This is an interventional diagnostic trial for Eosinophilic Esophagitis
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
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
NCT ID
NCT03834298
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
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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