Skip to main content
OpenTrials
Completed

NCT Number: NCT04416217

Eosinophilic Esophagitis Steroid Safety Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Athens Children's Hospital "AGIA SOPHIA", Athens, Greece

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Adrenal suppression

    Time frame: 3 months

    Rates of pathological adrenocorticotropic hormone (ACTH) tests at 3 and 12 months of topical steroid use

  2. Adrenal suppression

    Time frame: 12 months

    Rates of pathological adrenocorticotropic hormone (ACTH) tests at 3 and 12 months of topical steroid use

  3. Growth failure

    Time frame: 12 months

    Rates of decreased Height for age after 12 months of treatment.

  4. Growth failure

    Time frame: 36 months

    Rates of decreased Height for age after 12 months of treatment.

Secondary outcomes

  1. Bone mineral density

    Time frame: 12 months

    Decrease in bone mineral density between first and second dual energy x-ray absorptiometry (DEXA)

  2. Bone mineral density

    Time frame: 3 years

    Decrease in bone mineral density between first and second dual energy x-ray absorptiometry (DEXA)

  3. Hyperglycemia

    Time frame: 3 months

    Rates of elevated fasting glucose after 3 and 12 months of treatment

  4. Hyperglycemia

    Time frame: 12 months

    Rates of elevated fasting glucose after 3 and 12 months of treatment

  5. Elevated Liver Enzymes

    Time frame: 3 months

    Elevated ALT

  6. Histological remission 3 months

    Time frame: 3 months

    Histological remission at endoscopy timepoints

  7. Histological remission 12 months

    Time frame: 12 months

    Histological remission at endoscopy timepoints

  8. Clinical remission

    Time frame: 3 months

    Clinical remission at endoscopy time points according to PEESS v.2

  9. Clinical remission

    Time frame: 12 months

    Clinical remission at endoscopy time points according to PEESS v.2

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

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

Acronym: EESY

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jun 4, 2020
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.