Clinical trial NCT03834298: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Eosinophilic Esophagitis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: Ann & Robert H Lurie Children's Hospital of Chicago
First posted: 2019-02-07
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
timeFrame: 6 weeks
measure: Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
timeFrame: 2 weeks
measure: Disease Remission as Measured by Esophageal String Test (EST) Score (EoEScore)
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Symptom Severity in Participants Age 18-65 as Measured by Eosinophilic Esophagitis Activity Index (EESAI)
timeFrame: Baseline and 6 weeks
measure: Change in Symptom Severity in Participants Age 7-18 as Measured by Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS v 2.)
timeFrame: Baseline and 6 weeks
measure: Time to Disease Recurrence as Measured by EST score
timeFrame: 4 weeks after food re-introduction
measure: Time to Disease Recurrence as Measured by EST score
timeFrame: 2 weeks after food re-introduction
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Calies Menard-Katcher, MD
role: PRINCIPAL_INVESTIGATOR
References: