Metabolomic Profiling of Eosinophilic Esophagitis

Metabolomic Profiling of Eosinophilic Esophagitis Patients With Dysphagia for Biomarker Discovery

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

Study Overview

• Status: Withdrawn
• Conditions: Eosinophilic Esophagitis
• Intervention / Treatment: Procedure: Esophageal String Test

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: EST; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): October 17, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Hypersensitivity; Esophageal Diseases; Leukocyte Disorders; Eosinophilia; Eosinophilic Esophagitis; Esophagitis
• Other Study ID Numbers: 19-0074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No