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Fibrostenotic Eosinophilic Esophagitis: Assessment Tools

Fibrostenotic Eosinophilic Esophagitis: Endoscopic, Histologic and Molecular Characterization and Evaluation of Clinical Assessment Tools

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02453126
Enrollment
250
Registered
2015-05-25
Start date
2014-12-31
Completion date
2024-06-30
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic Esophagitis, Esophageal Stricture

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.

Interventions

None listed

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Stricture, as measured by endoscopic assessmentDay 1

Secondary

MeasureTime frame
Decreased esophageal distensibility, as determined by EndoFlipDay 1

Countries

United States

Contacts

Primary ContactCassandra Burger
cassandra.burger@childrenscolorado.org720-777-5739

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026