Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT02453126

Conditions

Eosinophilic Esophagitis

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Eosinophilic Esophagitis

Study ID

NCT02453126

Start date

Dec, 2014

Status verified date

Feb, 2024

Completion date

Jun, 2024

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Scheduled to undergo a clinical upper endoscopy with biopsy

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.)

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Stricture, as measured by endoscopic assessment [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Cassandra Burger

720-777-5739cassandra.burger@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Cassandra Burger

720-777-5739cassandra.burger@childrenscolorado.org

More Information

Sponsor

University of Colorado, Denver

Last update posted

Feb 5, 2024

Last verified

Feb, 2024

Keywords

  • Eosinophilic Esophagitis
  • Esophageal Stricture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-02-05.