Eosinophilic Esophagitis Clinical Trial
Official title:
Fibrostenotic Eosinophilic Esophagitis: Endoscopic, Histologic and Molecular Characterization and Evaluation of Clinical Assessment Tools
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.
| Status | Recruiting |
| Enrollment | 250 |
| Est. completion date | June 2024 |
| Est. primary completion date | June 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 5 Years to 18 Years |
| Eligibility | 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.) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Children's Hospital Colorado | Aurora | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| University of Colorado, Denver |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Stricture, as measured by endoscopic assessment | Day 1 | ||
| Secondary | Decreased esophageal distensibility, as determined by EndoFlip | Day 1 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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