Metabolomic Profiling of Eosinophilic Esophagitis

Not Applicable

Withdrawn

• Conditions: Eosinophilic Esophagitis
• Interventions: Procedure: Esophageal String Test

• Registration Number: NCT03803527
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-14
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-14
• Last Update Posted: 2019-10-17
• Study Start: 2019-12-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EST	Esophageal String Test	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

Primary Outcome Measures

Name	Time	Method
Brief Esophageal Dysphagia Questionnaire	Time of Endoscopic Procedure	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).