Eosinophilic Esophagitis Steroid Safety Study

Completed

• Conditions: Eosinophilic Esophagitis

• Registration Number: NCT04416217
• Lead Sponsor: Rabin Medical Center

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 the safety profile of the drug.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-07
• Study First Submitted: 2020-05-24
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-04
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-04
• Last Update Posted: 2025-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Growth failure	36 months	Rates of decreased Height for age after 12 months of treatment.
Adrenal suppression	12 months	Rates of pathological adrenocorticotropic hormone (ACTH) tests at 3 and 12 months of topical steroid use

Secondary Outcome Measures

Name	Time	Method
Bone mineral density	3 years	Decrease in bone mineral density between first and second dual energy x-ray absorptiometry (DEXA)
Histological remission 3 months	3 months	Histological remission at endoscopy timepoints
Hyperglycemia	12 months	Rates of elevated fasting glucose after 3 and 12 months of treatment
Clinical remission	12 months	Clinical remission at endoscopy time points according to PEESS v.2
Elevated Liver Enzymes	3 months	Elevated ALT
Histological remission 12 months	12 months	Histological remission at endoscopy timepoints

Trial Locations

Locations (4)

Athens Children's Hospital "AGIA SOPHIA"; 🇬🇷 Athens, Greece

Institute of Gastroenterology, Nutrition and Liver Diseases; Schneider Children's Medical Center of Israel; 🇮🇱 Petach Tikva, Israel

Department of Woman, Child and General and Specialized Surgery, University of the Campania "Luigi Vanvitelli"; 🇮🇹 Naples, Italy

Maternal and Child Health Department, Sapienza; 🇮🇹 Rome, Italy