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

Eosinophilic Esophagitis Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

• NCT number: NCT05309590
• Study type: Observational [Patient Registry]
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Status: Active, not recruiting
• Start date: May 2014
• Completion date: May 2025