Metabolomic Profiling of Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

Official title:

Metabolomic Profiling of Eosinophilic Esophagitis Patients With Dysphagia for Biomarker Discovery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03803527
• Other study ID #: 19-0074
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: October 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Procedure:
• Esophageal String Test
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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