- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03834298
Non-endoscopic Tracking of Disease Activity in Eosinophilic Esophagitis
March 28, 2023 updated by: University of Colorado, Denver
Non-endoscopic Tracking of Disease Activity During Dietary Interventions in Eosinophilic Esophagitis
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).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kendra M Kocher, BaS
- Phone Number: 720-777-5304
- Email: kendra.kocher@childrenscolorado.org
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Four Food Elimination Diet (FFED)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
Time Frame: 2 weeks
|
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.
|
2 weeks
|
Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Symptom Severity in Participants Age 18-65 as Measured by Eosinophilic Esophagitis Activity Index (EESAI)
Time Frame: Baseline and 6 weeks
|
The validated symptoms severity assessment tool Eosinophilic Esophagitis Activity Index (EESAI) will be used to assess severity in participants age 18 to 65.
|
Baseline and 6 weeks
|
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
|
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.
|
Baseline and 6 weeks
|
Time to Disease Recurrence as Measured by EST score
Time Frame: 4 weeks after food re-introduction
|
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.
|
4 weeks after food re-introduction
|
Time to Disease Recurrence as Measured by EST score
Time Frame: 2 weeks after food re-introduction
|
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.
|
2 weeks after food re-introduction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2021
Primary Completion (Anticipated)
August 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
January 4, 2019
First Submitted That Met QC Criteria
February 5, 2019
First Posted (Actual)
February 7, 2019
Study Record Updates
Last Update Posted (Actual)
March 31, 2023
Last Update Submitted That Met QC Criteria
March 28, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-0018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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