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Fibrostenotic Eosinophilic Esophagitis: Assessment Tools

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ClinicalTrials.gov Identifier: NCT02453126
Recruitment Status : Recruiting
First Posted : May 25, 2015
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease
Eosinophilic Esophagitis

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Fibrostenotic Eosinophilic Esophagitis: Endoscopic, Histologic and Molecular Characterization and Evaluation of Clinical Assessment Tools
Study Start Date : December 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

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U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Stricture, as measured by endoscopic assessment [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Decreased esophageal distensibility, as determined by EndoFlip [ Time Frame: Day 1 ]

Eligibility Criteria
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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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 )
First Posted: May 25, 2015    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

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