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

March 16, 2026 updated by: Joshua Wechsler, Ann & Robert H Lurie Children's Hospital of Chicago

Prospective Pilot Study Evaluating the Efficacy of Low-Dose Topical Steroids in Maintaining Histologic Remission of Eosinophilic Esophagitis in Children

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 choose to decrease the steroid dosing.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 short-term safety of topical steroids has been well established; however, long-term safety has not been studied in EoE. Concerns for long-term complications of chronic steroid therapy include effects on bone density and stature as has been suggested by literature in patients with asthma treated with inhaled corticosteroids chronically.4, 5 It remains unclear whether symptom and histologic remission, once achieved, can be maintained with a lower, to be defined, dosage of topical steroids.6 This is critical to prevent the major complications associated with uncontrolled eosinophilic inflammation: fibrotic remodeling (scarring) of the esophagus and eventual stricture (narrowing of the esophagus).7-11

Several studies have demonstrated that remission with induction (approximately 3 months of therapy) dose topical steroids resulted in resolution of inflammation and concurrent reversal of sub-epithelial early-stage fibrosis.12-18 It has not, however, been established whether fibrosis recurs when patients are maintained on induction doses long-term or whether lower "maintenance" dosing is sufficient. Studies are therefore needed to demonstrate whether fibrosis can be prevented from recurring long-term, ideally at a lower maintenance dose to minimize potential complications of therapy. Therapeutic strategies that achieve continuous and sustained remission with resolution of eosinophilic inflammation will prevent chronic symptoms along with remodeling, fibrosis and eventual esophageal stricture.

The rationale for utilizing lower dose topical steroids for maintaining clinical and histologic remission in children is the potential to lower the steroid-related side effects including contracting oral and/or esophageal fungal infections (a yeast infection which causes white patches in the mouth and throat), loss of bone density, suppression of adrenal-cortical axis (turns off the body's usual production of cortisol, which helps the body maintain a balance and respond to stress), and failure to achieve linear growth (height) potential. There are no studies that have properly quantified the risk of swallowed steroids in EoE, thus the investigators are presuming and postulating a lower cumulative risk of adverse effects from long-term use of the medication with this lower dose than the standard dose.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

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

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H Lurie Childjren's Hospital of Chicago

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

1 year to 21 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

By design, this study involves the participation of children. It is not anticipated that any other special groups be enrolled in a proportion other than that representative of the US population. Enrollment will not be limited by race or gender.

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dose Reduction
All patients recruited to the study will have reduced their swallowed steroid medication from twice to once daily as part of the standard-of-care.
Drug: Dose
The outcomes of reducing to half of the topical steroid (i.e. fluticasone [Flovent] and Swallowed viscous budesonide [Pulmicort]) will be observed with regards to whether the patients continue to be in histologic remission. These patients will have already achieved remission on a full dose of the steroid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Low Dose Topical Steroid
Time Frame: At standard of care endoscopies from the date of enrollment; estimated every 6-12 months
Number of patients who maintain histologic remission of low dose (50% dosing) topical steroids
At standard of care endoscopies from the date of enrollment; estimated every 6-12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual and histologic assessment of the esophagus
Time Frame: At standard of care endoscopies from the date of enrollment; estimated every 6-12 months
assess the change in visual findings on steroid or half dose steroid and whether patients were able to maintain visual and histologic remission when on low dose (50% dosing) topical steroids
At standard of care endoscopies from the date of enrollment; estimated every 6-12 months

Collaborators and Investigators

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

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

  • Principal Investigator: Joshua B Wechsler, MD, Ann & Robert H Lurie Children's hospital of Chicago

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)

May 1, 2014

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

March 24, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-15753

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Subscribe