Metabolomic Profiling of Eosinophilic Esophagitis

NCT03803527 | Withdrawn

• 1 other identifier: 19-0074
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

EST

EXPERIMENTAL

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

Interventions

Esophageal String Test PROCEDURE

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.

EST

Eligibility Criteria

• Age: 11 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Study Start: December 1, 2019
• Primary Completion: February 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 17, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share