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RecruitingNCT02453126Updated Feb 5, 2024

Fibrostenotic Eosinophilic Esophagitis: Assessment Tools

An observational study in Eosinophilic Esophagitis, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-02-05.

Sponsored by University of Colorado, Denver · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
250
Ages
5 Years to 18 Years
Sex
All
01

Study summary

This protocol addresses a central hypothesis that fibrostenotic Eosinophilic Esophagitis (EoE) is characterized by abnormal esophageal structure and compliance compared to non fibrostenotic EoE and that distinctive cellular and molecular profiles predict the fibrostenotic phenotype. This study aims to define and assess the changes that occur in the structure and dynamics of the esophageal wall in pediatric Eosinophilic Esophagitis along with characterizing the histologic and molecular patterns in fibrostenotic EoE.

02

Conditions studied

  • Eosinophilic Esophagitis

Keywords

  • Eosinophilic Esophagitis
  • Esophageal Stricture
03

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children, ages 5 to 18 years, scheduled to undergo a clinical upper endoscopy with biopsy for suspected or confirmed Eosinophilic Esophagitis.

Inclusion criteria

  • Scheduled to undergo a clinical upper endoscopy with biopsy

Exclusion criteria

Exclusion Criteria:

  • Known connective tissue disorder
  • Increased risk of bleeding
  • Inflammatory bowel disease, celiac disease, eosinophilic gastroenteritis, or any autoimmune disease
  • Other esophageal disease including known achalasia; history of caustic ingestion, esophageal surgery esophageal stricture for other known reason or other esophageal injury.
  • Use of oral or intravenous steroids in the preceding 60 days. (Swallowed topical fluticasone, budesonide, etc not included as exclusion criteria.)
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Stricture, as measured by endoscopic assessment

    Time frame: Day 1

Secondary outcomes

  1. Decreased esophageal distensibility, as determined by EndoFlip

    Time frame: Day 1

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT02453126
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
May 25, 2015
Start date
Dec 2014
Primary completion
Jun 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
Feb 5, 2024

Study contacts

Cassandra Burger
Contact
cassandra.burger@childrenscolorado.org
720-777-5739
Calies Menard-Katcher, MD
principal investigator · University of Colorado/Childrens Hospital Colorado

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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