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

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ClinicalTrials.gov Identifier: NCT03305653
Recruitment Status : Recruiting
First Posted : October 10, 2017
Last Update Posted : June 20, 2018
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Children's Hospital Colorado
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Device: Esophageal String Test (EST) Not Applicable

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):


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Use of Esophageal String Test to Understand Symptoms, Inflammation, and Function in Eosinophilic Esophagitis
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Current/historical diagnosis of EoE
Subjects with current or historical diagnosis of EoE, or suspected of having EoE will complete the Esophageal String Test (EST) and EndoFLIP
Device: Esophageal String Test (EST)
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 Measures :
  1. Measurement of Eosinophilic Degranulating Protein Concentration [ Time Frame: Measurement at one hour, when string is removed ]
    Measure the concentration of eosinophilic degranulating protein on strings that have been swallowed by subjects diagnosed with EoE



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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305653


Contacts
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Contact: Faria Ahmed 720-777-2797 faria.ahmed@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Faria Ahmed    720-777-2797    faria.ahmed@childrenscolorado.org   
Principal Investigator: Calies Menard-Katcher, MD         
Sub-Investigator: Glenn Furuta, MD         
Sponsors and Collaborators
University of Colorado, Denver
Children's Hospital of Philadelphia
Children's Hospital Colorado
Investigators
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Principal Investigator: Calies Menard-Katcher, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03305653     History of Changes
Other Study ID Numbers: 17-0796
First Posted: October 10, 2017    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Colorado, Denver:
Pediatrics

Additional relevant MeSH terms:
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Eosinophilic Esophagitis
Inflammation
Esophagitis
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases