Clinical trial NCT04416217: Eosinophilic Esophagitis Steroid Safety Study
Official title: Adrenal Suppression in Pediatric Eosinophilic Esophagitis Treated With Topical Steroids - A Multicenter, Prospective, Observational Safety Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eosinophilic Esophagitis
Keywords: Steroid , bone mineral density , DEXA , Adrenal
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 55
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients diagnosed with eosinophilic esophagitis for whom following discussion between the patient/gaurdians and physician treatment with topical steroids are planned.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adrenal suppression
timeFrame: 3 months
measure: Adrenal suppression
timeFrame: 12 months
measure: Growth failure
timeFrame: 12 months
measure: Growth failure
timeFrame: 36 months
Secondary outcomes:
measure: Bone mineral density
timeFrame: 12 months
measure: Bone mineral density
timeFrame: 3 years
measure: Hyperglycemia
timeFrame: 3 months
measure: Hyperglycemia
timeFrame: 12 months
measure: Elevated Liver Enzymes
timeFrame: 3 months
measure: Histological remission 3 months
timeFrame: 3 months
measure: Histological remission 12 months
timeFrame: 12 months
measure: Clinical remission
timeFrame: 3 months
measure: Clinical remission
timeFrame: 12 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Athens Children's Hospital "AGIA SOPHIA"
city: Petach Tikva
country: Israel
facility: Institute of Gastroenterology, Nutrition and Liver Diseases; Schneider Children's Medical Center of Israel
city: Naples
country: Italy
facility: Department of Woman, Child and General and Specialized Surgery, University of the Campania "Luigi Vanvitelli"
city: Rome
country: Italy
facility: Maternal and Child Health Department, Sapienza
Study officials:
References:
citation: Armstrong DH. Portable sampler for microorganisms in incinerator stack emissions. Appl Microbiol. 1970 Jan;19(1):204-5. doi: 10.1128/am.19.1.204-205.1970.
citation: Hsu S, Wood C, Pan Z, Rahat H, Zeitler P, Fleischer D, Menard-Katcher C, Furuta GT, Atkins D. Adrenal Insufficiency in Pediatric Eosinophilic Esophagitis Patients Treated with Swallowed Topical Steroids. Pediatr Allergy Immunol Pulmonol. 2017 Sep 1;30(3):135-140. doi: 10.1089/ped.2017.0779.
citation: Golekoh MC, Hornung LN, Mukkada VA, Khoury JC, Putnam PE, Backeljauw PF. Adrenal Insufficiency after Chronic Swallowed Glucocorticoid Therapy for Eosinophilic Esophagitis. J Pediatr. 2016 Mar;170:240-5. doi: 10.1016/j.jpeds.2015.11.026. Epub 2015 Dec 11.
citation: Harel S, Hursh BE, Chan ES, Avinashi V, Panagiotopoulos C. Adrenal insufficiency exists for both swallowed budesonide and fluticasone propionate in the treatment of eosinophilic esophagitis. J Pediatr. 2016 Jul;174:281. doi: 10.1016/j.jpeds.2016.02.056. Epub 2016 Mar 19. No abstract available.
citation: Philpott H, Dougherty MK, Reed CC, Caldwell M, Kirk D, Torpy DJ, Dellon ES. Systematic review: adrenal insufficiency secondary to swallowed topical corticosteroids in eosinophilic oesophagitis. Aliment Pharmacol Ther. 2018 Apr;47(8):1071-1078. doi: 10.1111/apt.14573. Epub 2018 Mar 5.