Status:

ACTIVE_NOT_RECRUITING

Efficacy of Low-Dose Topical Steroids in Maintaining Remission of Eosinophilic Esophagitis in Children

Lead Sponsor:

Ann & Robert H Lurie Children's Hospital of Chicago

Conditions:

Eosinophilic Esophagitis

Eligibility:

All Genders

1-21 years

Brief Summary

This study evaluates the decrease in steroid dosing for patients who have achieved remission on a full dose of steroids. Once a patient is in remission they will be enrolled in this study if they choo...

Detailed Description

As the disease usually recurs once steroids are discontinued, and there is concern for complications of untreated disease, continuation of steroids is indefinite after induction of remission. The shor...

Eligibility Criteria

Inclusion

  • Patients diagnosed with EoE
  • Patients less than 21 years of age at enrollment
  • Patients who within the past 12 months have demonstrated histologic remission (\<15 eos/hpf as assessed by upper esophagogastroduodenoscopy (EGD) with biopsy ) to the standard induction dose of topical steroids and have remained on this treatment:
  • Topical steroid treatment includes only those with previously published results: Swallowed topical fluticasone (i.e. Flovent®), and Swallowed viscous budesonide (i.e. Pulmicort Respules®) mixed with Honey or Splenda®
  • Patients who are interested in lowering their dose of topical steroids.

Exclusion

  • Patients with EoE who have not demonstrated histologic remission (\<15 eos/hpf) to topical steroids.
  • Patients who are unable or unwilling to take topical steroids.
  • Patients who have changed the vehicle or carrier (e.g. Splenda®or honey ) used to mix with the actual steroid drug, after demonstrating histologic remission.

Key Trial Info

Start Date :

May 1 2014

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

November 1 2025

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT05309590

Start Date

May 1 2014

End Date

November 1 2025

Last Update

November 27 2024

Active Locations (1)

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1

Ann & Robert H Lurie Childjren's Hospital of Chicago

Chicago, Illinois, United States, 60611