Eosinophilic Esophagitis Clinical Trial
The investigators hypothesize that swallowed beclomethasone leads not only to improvement of
symptoms and decreased number of eosinophils in esophageal mucosa, but also to a decrease in
other markers of tissue inflammation like mast cells, CD4+ T lymphocytes, IL4, IL-5, IL13,
GM-CSF and TGF-beta as well as serum ultra-sensitive C-Reactive Protein (CRP). The
investigators aim to characterize the response of esophageal inflammation to swallowed
topical glucocorticoids, and identify biomarkers to assess response to treatment.
This research will elucidate the effect of treatment with beclomethasone on various
inflammatory markers in EoE, which is currently not well-understood. This work will explore
the pathophysiology of EoE, and has the potential to find a non-invasive biomarker such as
high-sensitivity CRP that can be used to monitor the response to treatment.
EoE is an increasingly recognized clinicopathological diagnosis, characterized by a marked
accumulation of eosinophils in the esophageal mucosa.The presence of eosinophils and
association of the disease with food allergy and allergic rhinitis suggests an atopic
disease. Allergic diseases are associated with T-helper 2 lymphocytes (TH2) predominant
cytokines such as interleukins 4, 5, 13 (IL4, IL5, IL13), which are known to induce IgE
synthesis and promote eosinophilic infiltration. Granulocyte-Monocyte Colony Stimulating
Factor (GM-CSF) and Transforming Growth Factor (TGF) - beta are cytokines which are
associated with many eosinophilic disorders. Swallowed steroid is a conventional treatment
that has been shown to improve symptoms and decrease number of eosinophils in the esophagus
in patients with EoE. However, no studies have investigated the effect of swallowed steroid
on markers of TH2 inflammation in adult patients with EoE.Currently repeated endoscopic
biopsy of esophagus is the only tool to monitor response to treatment. Serum ultra-
sensitive CRP is a non-invasive marker of inflammation in cardiovascular and
gastrointestinal disorders. This study proposes to investigate the correlation of disease
activity with this potential marker of inflammation in adult patients with EoE which has not
been previously studied.
Specific Aim #1: To measure the baseline level of a proposed panel of inflammatory markers:
serum ultra-sensitive CRP and peripheral eosinophils, as well as tissue eosinophils, mast
cells, CD4 cells, IL-4, IL-5, IL-13, GM-CSF and TGF-beta in the esophagus in adult patients
with eosinophilic esophagitis.
Specific Aim #2: To determine the impact of 8 week course of treatment with swallowed
beclomethasone on the levels of the inflammatory markers measured in Specific Aim #1.
Specific Aim #3: To determine the correlation between the levels of the proposed panel of
inflammatory markers and symptoms of EoE before and after 8 weeks of treatment with
swallowed beclomethasone.
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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