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Metabolomic Profiling of Eosinophilic Esophagitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803527
Recruitment Status : Withdrawn (This study did not receive the grant that was applied for to conduct the study.)
First Posted : January 14, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Procedure: Esophageal String Test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Metabolomic Profiling of Eosinophilic Esophagitis Patients With Dysphagia for Biomarker Discovery
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : August 1, 2021


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.




Primary Outcome Measures :
  1. Brief Esophageal Dysphagia Questionnaire [ Time Frame: Time of Endoscopic Procedure ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03803527    
Other Study ID Numbers: 19-0074
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases