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

University Hospitals Cleveland Medical Center23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eosinophilic Esophagitis

Interventions

Fluticasone Propionate

Eligibility

Sex: ALLMin age: 4 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percent of Patients in Remission at One Year as Measured by EGD

The outcome measure is the number of participants who maintained remission (less than or equal to 15 eosinophils per high powered field in esophageal biopsies) for one year after demonstration of a therapeutic effect of topical steroid therapy.

Time frame: up to one year

Secondary Outcomes

Number of Patients Who Report Adverse Events as Measured by Patient Report

Time frame: up to 12 months

Number of Patients Who Develop Subclinical Adrenal Insufficiency as Measured by Blood Work

Subclinical adrenal insufficiency was defined as a morning cortisol level less than 10.0 micrograms per deciliter. One low level at anytime during the study period was recorded as an insufficient level.