Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis)

University Hospitals (UH)

Status and phase

Completed

Phase 4

Conditions

Eosinophilic Esophagitis

Treatments

Drug: Budesonide

Drug: Fluticasone Propionate

Study type

Interventional

Funder types

Other

Identifiers

NCT05444543

STUDY20210671

Details and patient eligibility

About

The purpose of our research study is to assess whether patients with EoE who have achieved control of their disease on topical Fluticasone or Budesonide are able to cycle or take breaks from their treatment with continued remission of their EoE. There will be 30 participants enrolled in this study. There will be 15 patients who will stay on steroid therapy every day and 15 patients who will cycle their steroid therapy on and off to help us compare the two groups. The cycling group will cycle their steroid therapy in a three-months on three-months off fashion.

Enrollment

23 patients

Sex

All

Ages

4 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Pediatric patients between 4-18 years of age with EoE followed by the Division of Pediatric Gastroenterology, Hepatology and Nutrition at Rainbow Babies and Children's Hospital
Patients who are currently on treatment with topical corticosteroids and scheduled for an upcoming endoscopy as part of their routine clinical care (to be used as EGD1) within 3 months of enrollment date
Patients who have achieved documented clinical and endoscopic remission using topical steroids as evidenced by EGD

Exclusion criteria

Patients who are not responsive to topical corticosteroid treatment for their EoE as evidenced by failure to obtain clinical or endoscopic remission on any pervious screening EGD
Patients less than 4 years of age and older than 18 years of age at the time of recruitment
Patients with history of or current diagnosis of esophageal strictures