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Use of Esophageal String Test to Understand Symptoms, Inflammation, and Function in Eosinophilic Esophagitis

Primary Purpose

Eosinophilic Esophagitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Esophageal String Test (EST)
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Eosinophilic Esophagitis focused on measuring Pediatrics

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provide signed and dated informed consent form.
  • Willing to comply with all study procedures and be available for the duration of the study.
  • Male or female, aged 7 to 18 years old, inclusive
  • Undergoing upper Endoscopy with biopsy for clinical care at CHCO or CHOP
  • Current or historical diagnosis of EoE, or suspected of having EoE

Exclusion Criteria:

  • Known connective tissue disease, other eosinophilic disorders
  • Past history of caustic injestion, esophageal surgery or other esophageal injury
  • Known inflammatory bowel disease or esophageal motility disease (achalasia)
  • Unwilling or unable to swallow the EST
  • Oral or intravenous steroids in the preceding 60 days (not including swallowed topical fluticasone, budesonide, etc)
  • Pregnancy
  • Participation in a clinical study that may interfere with participation in this study

Sites / Locations

  • Children's Hospital Colorado

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Current/historical diagnosis of EoE

Arm Description

Subjects with current or historical diagnosis of EoE, or suspected of having EoE will complete the Esophageal String Test (EST) and EndoFLIP

Outcomes

Primary Outcome Measures

Measurement of Eosinophilic Degranulating Protein Concentration
Measure the concentration of eosinophilic degranulating protein on strings that have been swallowed by subjects diagnosed with EoE

Secondary Outcome Measures

Full Information

First Posted
October 4, 2017
Last Updated
July 2, 2021
Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital of Philadelphia, Children's Hospital Colorado
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1. Study Identification

Unique Protocol Identification Number
NCT03305653
Brief Title
Use of Esophageal String Test to Understand Symptoms, Inflammation, and Function in Eosinophilic Esophagitis
Official Title
Use of Esophageal String Test to Understand Symptoms, Inflammation, and Function in Eosinophilic Esophagitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital of Philadelphia, Children's Hospital Colorado

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Presently, the only method available to monitor disease activity in Eosinophilic Esophagitis (EoE) is endoscopy with pathological review of biopsies. The overall goal of this study is to determine the ability of the Esophageal String Test (EST), a minimally invasive capsule based technology, to measure disease activity in children with EoE. Additionally, to determine esophageal distensibility in children presenting with EoE by using the EndoFLIP (functional luminal imaging probe) device during endoscopic procedures.
Detailed Description
When children are scheduled to undergo an endoscopy, research assistants will contact the family to arrange for the Esophageal String Test (EST) to be performed within one week of the endoscopy. The string test involves swallowing a small capsule with a thin piece of string inside it. The string unravels as the capsule goes down into the stomach. The investigator would tape the end of the string to the child's cheek, leaving it there for one hour. At the end of the hour, the investigator would remove the string by gently pulling it out through the mouth. Prior to swallowing the EST, the patient will complete the PEESS form (Pediatric Eosinophilic Esophagitis Symptom Scores) to assess symptoms. The endoscopy and Endoscopic Reference System (EREFs) and EndoFLIP will be performed. The EndoFLIP is a slender probe covered by a smooth long balloon that is passed into the esophagus and slowly expanded with a salt solution. After standard of care endoscopic visualization, the FLIP, a 16 cm probe (Crospon) will be placed transorally and positioned 3 cm distal to the lower esophageal sphincter. Esophageal cross sectional areas and intrabag pressure will be measured during stepwise distensions beginning with 5 mL and increasing to a maximum of 70mL or intrabag pressure of 50 mmHg is achieved, whichever comes first. FLIP is FDA-approved without age restriction and its use has been approved by our IRBs previously. Primary results will be reported as distensibility plateau (mm). Endoscopic severity: Endoscopic esophageal appearances will be scored using a validated EoE scoring system (EREFS). Five features of EoE will be scored: Edema (0-1), Rings (0-3) Exudates (0-2), Furrows (0-1), Stricture (0-1). Results will be reported as an inflammatory score (edema, exudates, furrows) and fibrostenotic score (rings, stricture). Functional Luminal Imaging Probe (FLIP):

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
Pediatrics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Current/historical diagnosis of EoE
Arm Type
Experimental
Arm Description
Subjects with current or historical diagnosis of EoE, or suspected of having EoE will complete the Esophageal String Test (EST) and EndoFLIP
Intervention Type
Device
Intervention Name(s)
Esophageal String Test (EST)
Intervention Description
The EST is a gelatin capsule filled with a 90cm nylon string. A trailing end of the string protrudes from one end of the capsule. This end is taped to the cheek and the capsule is swallowed. As the capsule travels to the small intestine, the string inside the capsule is dislodged, leaving a string that goes from the cheek to the small intestine. The capsule dislodges from the string and the string is left in place, in the mouth, esophagus, stomach and small intestine for an hour. During this time, the string rubs against the inside of the esophagus and collects eosinophil proteins. After one hour, the string is removed through the mouth and placed in preservative to save the eosinophil proteins.
Primary Outcome Measure Information:
Title
Measurement of Eosinophilic Degranulating Protein Concentration
Description
Measure the concentration of eosinophilic degranulating protein on strings that have been swallowed by subjects diagnosed with EoE
Time Frame
Measurement at one hour, when string is removed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provide signed and dated informed consent form. Willing to comply with all study procedures and be available for the duration of the study. Male or female, aged 7 to 18 years old, inclusive Undergoing upper Endoscopy with biopsy for clinical care at CHCO or CHOP Current or historical diagnosis of EoE, or suspected of having EoE Exclusion Criteria: Known connective tissue disease, other eosinophilic disorders Past history of caustic injestion, esophageal surgery or other esophageal injury Known inflammatory bowel disease or esophageal motility disease (achalasia) Unwilling or unable to swallow the EST Oral or intravenous steroids in the preceding 60 days (not including swallowed topical fluticasone, budesonide, etc) Pregnancy Participation in a clinical study that may interfere with participation in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Calies Menard-Katcher, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of Esophageal String Test to Understand Symptoms, Inflammation, and Function in Eosinophilic Esophagitis

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