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Fibrostenotic Eosinophilic Esophagitis: Assessment Tools

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 5 Years - 18 Years
Gender All
More 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.)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Colorado, Denver
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Calies Menard-Katcher, MD
Principal Investigator Affiliation University of Colorado/Childrens Hospital Colorado
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital Colorado, Aurora, Colorado




Children's Hospital Colorado

Aurora, Colorado, 80045

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