Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
55 participants
OBSERVATIONAL
2019-10-07
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Topical Steroid Treatment
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Noam Zevit
Attending Pediatric Gastroenterologist
Locations
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Athens Children's Hospital "AGIA SOPHIA"
Athens, , Greece
Institute of Gastroenterology, Nutrition and Liver Diseases; Schneider Children's Medical Center of Israel
Petah 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
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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0521-19-RMC
Identifier Type: -
Identifier Source: org_study_id
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