Back to resultsMetabolomic Profiling of Eosinophilic Esophagitis
Primary Purpose
Eosinophilic Esophagitis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Esophageal String Test
Sponsored by
About this trial
This is an interventional diagnostic trial for Eosinophilic Esophagitis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EST
Arm 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
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03803527
First Posted
January 10, 2019
Last Updated
October 14, 2019
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT03803527
Brief Title
Metabolomic Profiling of Eosinophilic Esophagitis
Official Title
Metabolomic Profiling of Eosinophilic Esophagitis Patients With Dysphagia for Biomarker Discovery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Withdrawn
Why Stopped
This study did not receive the grant that was applied for to conduct the study.
Study Start Date
December 1, 2019 (Anticipated)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EST
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Esophageal String Test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brief Esophageal Dysphagia Questionnaire
Description
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 Frame
Time of Endoscopic Procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Metabolomic Profiling of Eosinophilic Esophagitis
We'll reach out to this number within 24 hrs