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Fibrostenotic Eosinophilic Esophagitis: Assessment Tools
This study is currently recruiting participants.
Verified November 2016 by University of Colorado, Denver
Sponsor:
University of Colorado, Denver
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02453126
First received: September 16, 2014
Last updated: November 16, 2016
Last verified: November 2016
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Purpose
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.
| Condition |
|---|
| Eosinophilic Esophagitis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Fibrostenotic Eosinophilic Esophagitis: Endoscopic, Histologic and Molecular Characterization and Evaluation of Clinical Assessment Tools |
Resource links provided by NLM:
Further study details as provided by University of Colorado, Denver:
Primary Outcome Measures:
- Stricture, as measured by endoscopic assessment [ Time Frame: Day 1 ]
Secondary Outcome Measures:
- Decreased esophageal distensibility, as determined by EndoFlip [ Time Frame: Day 1 ]
| Estimated Enrollment: | 150 |
| Study Start Date: | December 2014 |
| Estimated Study Completion Date: | January 2018 |
| Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 5 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Children, ages 5 to 18 years, scheduled to undergo a clinical upper endoscopy with biopsy for suspected or confirmed Eosinophilic Esophagitis.
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.)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02453126
Please refer to this study by its ClinicalTrials.gov identifier: NCT02453126
Contacts
| Contact: Faria Ahmed | 720-777-2797 | faria.ahmed@childrenscolorado.org |
Locations
| United States, Colorado | |
| Children's Hospital Colorado | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Faria Ahmed 720-777-2797 faria.ahmed@childrenscolorado.org | |
Sponsors and Collaborators
University of Colorado, Denver
Investigators
| Principal Investigator: | Calies Menard-Katcher, MD | University of Colorado/Childrens Hospital Colorado |
More Information
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT02453126 History of Changes |
| Other Study ID Numbers: |
14-0594 UL1TR001082 ( U.S. NIH Grant/Contract ) |
| Study First Received: | September 16, 2014 |
| Last Updated: | November 16, 2016 |
Keywords provided by University of Colorado, Denver:
|
Eosinophilic Esophagitis Esophageal Stricture |
Additional relevant MeSH terms:
|
Esophagitis Eosinophilic Esophagitis Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |
Eosinophilia Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on September 19, 2017