Eosinophilic Esophagitis Steroid Safety Study (EESY)

Clalit Health Services

Status: Enrolling

Conditions: Eosinophilic Esophagitis

Study type: Observational

Funder types: Other

Identifiers

NCT04416217

0521-19-RMC

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No 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.

Trial design

300 participants in 1 patient group

Topical Steroid Treatment

Description:

Pediatric patients with eosinophilic esophagitis scheduled to begin topical steroid treatment for the treatment of their condition. The type of topical steroid is not limited and is at the discretion of the treating physician as are dosing and concomitant treatments.