Eosinophilic Esophagitis Steroid Safety Study (EESY)

March 28, 2023 updated by: Noam Zevit, Rabin Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Athens, Greece, 115 27
  • Israel
      • Petach Tikva, Israel, 49202
        • Recruiting
        • Institute of Gastroenterology, Nutrition and Liver Diseases; Schneider Children's Medical Center of Israel
        • Contact:
        • Principal Investigator:
          • Noam Zevit, M.D.
  • Italy
      • Naples, Italy
        • Recruiting
        • Department of Woman, Child and General and Specialized Surgery, University of the Campania "Luigi Vanvitelli"
        • Contact:
          • Caterina Strisciuglio
        • Contact:
      • Rome, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adrenal suppression
Time Frame: 3 months
Rates of pathological adrenocorticotropic hormone (ACTH) tests at 3 and 12 months of topical steroid use
3 months
Adrenal suppression
Time Frame: 12 months
Rates of pathological adrenocorticotropic hormone (ACTH) tests at 3 and 12 months of topical steroid use
12 months
Growth failure
Time Frame: 12 months
Rates of decreased Height for age after 12 months of treatment.
12 months
Growth failure
Time Frame: 36 months
Rates of decreased Height for age after 12 months of treatment.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone mineral density
Time Frame: 12 months
Decrease in bone mineral density between first and second dual energy x-ray absorptiometry (DEXA)
12 months
Bone mineral density
Time Frame: 3 years
Decrease in bone mineral density between first and second dual energy x-ray absorptiometry (DEXA)
3 years
Hyperglycemia
Time Frame: 3 months
Rates of elevated fasting glucose after 3 and 12 months of treatment
3 months
Hyperglycemia
Time Frame: 12 months
Rates of elevated fasting glucose after 3 and 12 months of treatment
12 months
Elevated Liver Enzymes
Time Frame: 3 months
Elevated ALT
3 months
Histological remission 3 months
Time Frame: 3 months
Histological remission at endoscopy timepoints
3 months
Histological remission 12 months
Time Frame: 12 months
Histological remission at endoscopy timepoints
12 months
Clinical remission
Time Frame: 3 months
Clinical remission at endoscopy time points according to PEESS v.2
3 months
Clinical remission
Time Frame: 12 months
Clinical remission at endoscopy time points according to PEESS v.2
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2019

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

May 24, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0521-19-RMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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