Eosinophilic Esophagitis Steroid Safety Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Eosinophilic Esophagitis

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Topical Steroid Treatment<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adrenal suppression | Rates of pathological adrenocorticotropic hormone (ACTH) tests at 3 and 12 months of topical steroid use | 3 months | 
| Adrenal suppression | Rates of pathological adrenocorticotropic hormone (ACTH) tests at 3 and 12 months of topical steroid use | 12 months | 
| Growth failure | Rates of decreased Height for age after 12 months of treatment. | 12 months | 
| Growth failure | Rates of decreased Height for age after 12 months of treatment. | 36 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Steroid , bone mineral density , DEXA , Adrenal