Metabolomic Profiling of Eosinophilic Esophagitis

Study Overview
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Brief Summary
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A prospective longitudinal, observational study of adolescent and adults that will identify novel metabolites associated with dysphagia in Eosinophilic Esophagitis (EoE).

Detailed Description
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In this study, the investigators seek to understand whether a metabolomic profile obtained from esophageal samples correlate with the symptom of dysphagia in adolescent and adults. The investigators hypothesize that intraluminal secreted metabolite(s) will change during episodes of dysphagia. The aim of the study will be to use a novel method of producing esophageal luminal samples, the esophageal string test, to capture esophageal metabolites when a patient is and is not experiencing dysphagia.

Official Title
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Metabolomic Profiling of Eosinophilic Esophagitis Patients With Dysphagia for Biomarker Discovery

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Procedure: Esophageal String Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with Eosinophilic Esophagitis (EoE) and seen either at Children's Hospital Colorado or University of Colorado Hospital for scheduled outpatient clinical assessment or upper GI endoscopy Exclusion Criteria: Acute food impaction at time of study Recent (within 2 months) use of systemic steroids Other known esophageal disease or esophageal injury (e.g. tracheoesophageal fistula, congenital stricture, caustic injury) known other inflammatory bowel disease inability to swallow the EST

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EST<br>All subjects enrolled into the study will: Complete a clinical history Have vitals obtained Complete Patient-reported outcomes Have Esophageal mucosal biopsies collected as part of standard of care at the time of the most recent endoscopy to report the peak eosinophilia per hpf. Complete the Esophageal String test | Procedure: Esophageal String Test<br>* An EST will be performed for a 1hour sampling period on the same day as the scheduled clinic visit. Subjects will be asked to swallow a capsule and the attached EST string will be taped to the cheek with tegaderm tape. At the completion of the 1-hour sampling period, the EST will be removed and it will immediately be processed and cryopreserved for metabolomics profiling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Esophageal Dysphagia Questionnaire | Positive Dysphagia symptoms Measured by Brief Esophageal Dysphagia Questionnaire. The questionnaire asks questions about dysphagia symptoms and the scale is from 0 (rarely/never) to 5 (several times per day). | Time of Endoscopic Procedure |