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OpenTrials
Completed

NCT Number: NCT03305653

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

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.

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Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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):

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophageal String Test (EST)

Device

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Children's Hospital Colorado
  • Children's Hospital of Philadelphia

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 10, 2017
Registry last updated
Jul 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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