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

NCT03305653 | Completed Results FDA Device

• 1 other identifier: 17-0796
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis

Keywords

Pediatrics

Outcome Measures

Primary Outcomes (1)

• Measurement of Eosinophilic Degranulating Protein Concentration

  Measure the concentration of eosinophilic degranulating protein on strings that have been swallowed by subjects diagnosed with EoE

  Measurement at one hour, when string is removed

Study Arms (1)

Current/historical diagnosis of EoE

EXPERIMENTAL

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)

Interventions

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.

Current/historical diagnosis of EoE

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Children's Hospital of Philadelphia: collaborator
• Children's Hospital Colorado: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Calies Menard-Katcher
• Organization: Children's Hospital Colorado

calies.menard-katcher@childrenscolorado.org

720-777-2318

Study Officials

• Calies Menard-Katcher, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 10, 2017
• Study Start: May 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: July 6, 2021
• Results First Posted: July 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)