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Eosinophilic Esophagitis Steroid Safety Study

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A - 18 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04416217
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Rabin Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Israel, Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis
Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Petach Tikva, Israel

Status

Recruiting

Address

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

Petach Tikva, , 49202

Site Contact

Noam Zevit, M.D.

noamze@clalit.org.il

972-3-9253673

Naples, Italy

Status

Recruiting

Address

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

Naples, ,

Site Contact

Caterina Strisciuglio

nzevit@gmail.com

972-3-9253673

Rome, Italy

Status

Recruiting

Address

Maternal and Child Health Department, Sapienza

Rome, ,

Site Contact

Salvatore Oliva, M.D.

nzevit@gmail.com

972-3-9253673

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