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Metabolomic Profiling of Eosinophilic Esophagitis

Metabolomic Profiling of Eosinophilic Esophagitis Patients With Dysphagia for Biomarker Discovery

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03803527
Enrollment
0
Registered
2019-01-14
Start date
2019-12-01
Completion date
2021-08-01
Last updated
2019-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

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.

Interventions

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.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Brief Esophageal Dysphagia QuestionnaireTime of Endoscopic ProcedurePositive 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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026