Eosinophilic Esophagitis Steroid Safety Study

Eosinophilic Esophagitis Clinical Trial

— EESY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04416217
• Other study ID #: 0521-19-RMC
• Status: Recruiting
• Start date: October 7, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Rabin Medical Center
• Contact: Noam Zevit, M.D.
• Phone: 972-3-9253673
• Email: nzevit[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Locations

Country	Name	City	State
Greece	Athens Children's Hospital "AGIA SOPHIA"	Athens
Israel	Institute of Gastroenterology, Nutrition and Liver Diseases; Schneider Children's Medical Center of Israel	Petach Tikva
Italy	Department of Woman, Child and General and Specialized Surgery, University of the Campania "Luigi Vanvitelli"	Naples
Italy	Maternal and Child Health Department, Sapienza	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Countries where clinical trial is conducted

Greece,  Israel,  Italy, 

References & Publications (5)

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. — View 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. — View 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. — View Citation

Lucendo AJ, Molina-Infante J, Arias A, von Arnim U, Bredenoord AJ, Bussmann C, Amil Dias J, Bove M, Gonzalez-Cervera J, Larsson H, Miehlke S, Papadopoulou A, Rodriguez-Sanchez J, Ravelli A, Ronkainen J, Santander C, Schoepfer AM, Storr MA, Terreehorst I, Straumann A, Attwood SE. Guidelines on eosinophilic esophagitis: evidence-based statements and recommendations for diagnosis and management in children and adults. United European Gastroenterol J. 2017 Apr;5(3):335-358. doi: 10.1177/2050640616689525. Epub 2017 Jan 23. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adrenal suppression	Rates of pathological adrenocorticotropic hormone (ACTH) tests at 3 and 12 months of topical steroid use	3 months
Primary	Adrenal suppression	Rates of pathological adrenocorticotropic hormone (ACTH) tests at 3 and 12 months of topical steroid use	12 months
Primary	Growth failure	Rates of decreased Height for age after 12 months of treatment.	12 months
Primary	Growth failure	Rates of decreased Height for age after 12 months of treatment.	36 months
Secondary	Bone mineral density	Decrease in bone mineral density between first and second dual energy x-ray absorptiometry (DEXA)	12 months
Secondary	Bone mineral density	Decrease in bone mineral density between first and second dual energy x-ray absorptiometry (DEXA)	3 years
Secondary	Hyperglycemia	Rates of elevated fasting glucose after 3 and 12 months of treatment	3 months
Secondary	Hyperglycemia	Rates of elevated fasting glucose after 3 and 12 months of treatment	12 months
Secondary	Elevated Liver Enzymes	Elevated ALT	3 months
Secondary	Histological remission 3 months	Histological remission at endoscopy timepoints	3 months
Secondary	Histological remission 12 months	Histological remission at endoscopy timepoints	12 months
Secondary	Clinical remission	Clinical remission at endoscopy time points according to PEESS v.2	3 months
Secondary	Clinical remission	Clinical remission at endoscopy time points according to PEESS v.2	12 months