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Eosinophilic Esophagitis Steroid Safety Study | Clinical Trials | Clareo Health

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Eosinophilic Esophagitis Steroid Safety Study

Adrenal Suppression in Pediatric Eosinophilic Esophagitis Treated With Topical Steroids - A Multicenter, Prospective, Observational Safety Study

NCT04416217•Rabin Medical Center

View on ClinicalTrials.gov

Summary

This observational study will follow pediatric patients with eosinophilic esophagitis who are scheduled to begin topical steroid treatment, from the initiation of treatment longitudinally to determine the safety profile of the drug.

Eligibility

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age \<18 years at the time of enrollment.
•2. Males and Females are included.
•3. Patients diagnosed with EoE as defined by age appropriate signs of esophageal dysfunction (in older children and adolescents - dysphagia, impacted food bolus, foreign body impaction, vomiting, and GERD not responsive to high dose proton pump inhibitors. In infants and young children - failure to thrive, poor feeding, vomiting, food bolus impaction)
•4. Histopathological finding of ≥15 eosinophils/high power field (X400) on at least one esophageal biopsy.
•5. After discussing the available treatment options with the gastroenterologist, the patient has chosen oral topical steroid treatment (either as a first treatment or after failure of other dietary or medical treatment).

Exclusion Criteria

•1. Known alternative causes of esophageal eosinophilia.
•2. Legal guardian unable or unwilling to sign informed consent..
•3. Known allergy to topical steroids ingredients
•4. Patient will not be available for follow-up for at least the 3 month assessment and ACTH test.
•5. Known pregnancy
•6. Use of oral systemic steroids in the 6 months prior to inclusion in the study. Use of systemic steroids once in the study will not lead to study termination, but such use will need to be reported in the medication changes and use page of the following visit.

Locations (4)

Athens Children's Hospital "AGIA SOPHIA"

Athens, Greece

Institute of Gastroenterology, Nutrition and Liver Diseases; Schneider Children's Medical Center of Israel

Petah Tikva, Israel

Department of Woman, Child and General and Specialized Surgery, University of the Campania "Luigi Vanvitelli"

Naples, Italy

Maternal and Child Health Department, Sapienza

Rome, Italy

Key Dates

Start Date

October 7, 2019

Primary Completion Date

December 31, 2024

Completion Date

December 31, 2024

Last Updated

May 7, 2025

Enrollment

ACTUAL participants

Conditions

Eosinophilic Esophagitis

A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

NCT06693531

Eosinophilic Esophagitis (EoE)

View study

RECRUITING

Eosinophilic Gastrointestinal Disorders Registry

NCT05199532

Eosinophilic EsophagitisEosinophilic Gastroenteritis+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Eosinophilic Esophagitis Steroid Safety Study

Inclusion Criteria

Exclusion Criteria

A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

Eosinophilic Gastrointestinal Disorders Registry

Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

Prospective Registry of EoSinophilic esOphagitis

Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy

Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE