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

NCT05309590 | Active Not Recruiting

• 1 other identifier: 2014-15753
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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 choose to decrease the steroid dosing.

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

• Efficacy of Low Dose Topical Steroid

  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 Outcomes (1)

• Visual and histologic assessment of the esophagus

  At standard of care endoscopies from the date of enrollment; estimated every 6-12 months

Study Arms (1)

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

Interventions

Dose DRUG

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.

Dose Reduction

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H Lurie Childjren's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (21)

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  BACKGROUND

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MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Joshua B Wechsler, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: April 4, 2022
• Study Start: May 1, 2014
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (1)