Eosinophilic Esophagitis
Conditions
Keywords
Steroid , bone mineral density , DEXA , Adrenal
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.
Interventions
None listed
Sponsors
Rabin Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adrenal suppression | 3 months | Rates of pathological adrenocorticotropic hormone (ACTH) tests at 3 and 12 months of topical steroid use |
| Growth failure | 12 months | Rates of decreased Height for age after 12 months of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histological remission 3 months | 3 months | Histological remission at endoscopy timepoints |
| Histological remission 12 months | 12 months | Histological remission at endoscopy timepoints |
| Clinical remission | 3 months | Clinical remission at endoscopy time points according to PEESS v.2 |
| Hyperglycemia | 3 months | Rates of elevated fasting glucose after 3 and 12 months of treatment |
| Bone mineral density | 12 months | Decrease in bone mineral density between first and second dual energy x-ray absorptiometry (DEXA) |
| Elevated Liver Enzymes | 3 months | Elevated ALT |
Countries
Greece, Israel, Italy
Outcome results
None listed