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Metabolomic Profiling of Eosinophilic Esophagitis

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Withdrawn

Conditions

Eosinophilic Esophagitis

Treatments

Procedure: Esophageal String Test

Study type

Interventional

Funder types

Other

Identifiers

NCT03803527
19-0074

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

11 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

EST
Experimental group
Description:
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
Treatment:
Procedure: Esophageal String Test

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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