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 5 August 2020
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 18years or below
Clinical Study IdentifierNCT04416217
SponsorRabin Medical Center
Last Modified on5 August 2020

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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eosinophil count
vomiting
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proton pump inhibitors
systemic steroids
gastroesophageal reflux
esophagitis
failure to thrive
esophageal biopsy
vomit
pediatric
acid reflux / gastroesophageal reflux
bolus impaction

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