Fibrostenotic Eosinophilic Esophagitis: Assessment Tools

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Enrolling

Conditions

Eosinophilic Esophagitis

Study type

Observational

Funder types

Other

Identifiers

NCT02453126
14-0594
UL1TR001082 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

5 to 18 years old

Volunteers

No Healthy Volunteers

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.)

Trial contacts and locations

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Central trial contact

Cassandra Burger

Data sourced from clinicaltrials.gov

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