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

Official Title: Prospective Pilot Study of Low-Dose Topical Steroids in Maintaining Histologic Remission of Eosinophilic Esophagitis in Children

Eosinophilic esophagitis (EoE) is emerging recently identified immune-mediated allergic, inflammatory disorder of the esophagus (the food pipe that runs from the mouth to the stomach) triggered by food or environmental allergens. The natural history of EoE is poorly defined; however it appears to be a chronic disorder with long-term complications and morbidity. Treatment in children is family-centered and the standard of care includes either topical (swallowed) steroids or dietary elimination. Although both modalities induce clinical and histologic (changes on the cellular level) remission in a majority of treated patients, topical steroids are more frequently offered in both children and adults because of the ease of administration, high remission rate, and ability to maintain all foods in the diet. 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. It remains unclear whether symptom and histologic remission, once achieved, can be maintained with a lower, to be defined, dosage of topical steroids. 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). 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 we 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.
Wechsler, Joshua B., MD, MS

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Katie Keeley

Clinical Research Coordinator