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Fibrostenotic Eosinophilic Esophagitis: Assessment Tools

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by University of Colorado, Denver
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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 July 24, 2017