Eosinophilic Esophagitis Steroid Safety Study

NCT04416217 | Completed

• 1 other identifier: 0521-19-RMC
• Study Type: observational
• Target: 55
• Locations: 3 countries
• Sites: 4

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.

Conditions

Eosinophilic Esophagitis

Keywords

Steroid , bone mineral density , DEXA , Adrenal

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Bone mineral density

  12 months

• Bone mineral density

  3 years

• Hyperglycemia

  3 months

• Hyperglycemia

  12 months

• Elevated Liver Enzymes

  3 months

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (4)

Athens Children's Hospital "AGIA SOPHIA"

Athens, 115 27, Greece

Location

Institute of Gastroenterology, Nutrition and Liver Diseases; Schneider Children's Medical Center of Israel

Petah Tikva, 49202, Israel

Location

Department of Woman, Child and General and Specialized Surgery, University of the Campania "Luigi Vanvitelli"

Naples, Italy

Location

Maternal and Child Health Department, Sapienza

Rome, Italy

Location

Related Publications (5)

• 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.

  PMID: 5415218 BACKGROUND

• 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.

  PMID: 29062584 BACKGROUND

• 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.

  PMID: 26687577 BACKGROUND

• 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.

  PMID: 27004676 BACKGROUND

• 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.

  PMID: 29508432 BACKGROUND

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Pediatric Gastroenterologist

Study Record Dates

• First Submitted: May 24, 2020
• First Posted: June 4, 2020
• Study Start: October 7, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

IL (1); IT (2); GR (1)