Status:
COMPLETED
Eosinophilic Esophagitis Steroid Safety Study
Lead Sponsor:
Rabin Medical Center
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
Up to 18 years
Brief 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...
Eligibility Criteria
Inclusion
- Age \<18 years at the time of enrollment.
- Males and Females are included.
- 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)
- Histopathological finding of ≥15 eosinophils/high power field (X400) on at least one esophageal biopsy.
- 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
- Known alternative causes of esophageal eosinophilia.
- Legal guardian unable or unwilling to sign informed consent..
- Known allergy to topical steroids ingredients
- Patient will not be available for follow-up for at least the 3 month assessment and ACTH test.
- Known pregnancy
- 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.
Key Trial Info
Start Date :
October 7 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04416217
Start Date
October 7 2019
End Date
December 31 2024
Last Update
May 7 2025
Active Locations (4)
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1
Athens Children's Hospital "AGIA SOPHIA"
Athens, Greece, 115 27
2
Institute of Gastroenterology, Nutrition and Liver Diseases; Schneider Children's Medical Center of Israel
Petah Tikva, Israel, 49202
3
Department of Woman, Child and General and Specialized Surgery, University of the Campania "Luigi Vanvitelli"
Naples, Italy
4
Maternal and Child Health Department, Sapienza
Rome, Italy