Assessing esophageal changes in children with Eosinophilic Esophagitis
Fibrostenotic Eosinophilic Esophagitis: Endoscopic, Histologic and Molecular Characterization and Evaluation of Clinical Assessment Tools
This study is trying to see how the esophagus differs in children with a specific type of Eosinophilic Esophagitis compared to another type, to help improve diagnosis and understanding of the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT02453126 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the structural and compliance differences in the esophagus of pediatric patients with fibrostenotic Eosinophilic Esophagitis (EoE) compared to those with non-fibrostenotic EoE. It aims to identify distinctive cellular and molecular profiles that predict the fibrostenotic phenotype. By analyzing changes in the esophageal wall and characterizing histologic and molecular patterns, the study seeks to enhance understanding of this condition and improve diagnostic tools.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients scheduled for a clinical upper endoscopy with biopsy due to suspected Eosinophilic Esophagitis.
Not a fit: Patients with known connective tissue disorders, inflammatory bowel disease, or other significant esophageal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnostic and treatment strategies for children suffering from Eosinophilic Esophagitis.
How similar studies have performed: While there is ongoing research in Eosinophilic Esophagitis, this specific approach focusing on fibrostenotic EoE is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Aurora, Colorado
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Calies Menard-Katcher, MD — University of Colorado/Childrens Hospital Colorado
- Study coordinator: Cassandra Burger
- Email: cassandra.burger@childrenscolorado.org
- Phone: 720-777-5739
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.