Eosinophilic Esophagitis Steroid Safety Study

STATUS

Recruiting
End date

Dec 31, 2025
participants needed

300
sponsor

Rabin Medical Center

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Updated on 19 February 2024

See if I qualify

eosinophil count

vomiting

dysphagia

steroid therapy

proton pump inhibitors

systemic steroids

gastroesophageal reflux

esophagitis

failure to thrive

esophageal biopsy

vomit

pediatric

acid reflux / gastroesophageal reflux

bolus impaction

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.

Details

Condition	Eosinophilic esophagitis
Age	18 years and younger
Clinical Study Identifier	NCT04416217
Sponsor	Rabin Medical Center
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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 Criteria
	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

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Study Definition

Wikipedia

Eosinophilic Esophagitis Steroid Safety Study