The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis

Hypotheses:

1. There is a subset of patients with the diagnosis of EE who also have GERD.

2. Patients with both EE and GERD will respond symptomatically and histologically to
aggressive gastric acid suppression with a proton pump inhibitor as monotherapy.

3. Swallowed budesonide suspension is effective in treating patients with EE who do not
have evidence of GERD.

Participants were randomized based on results of a 24 hour pH study, which determined the
average percent time the distal esophagus was exposed to a pH of less than than 4. Subjects
with a positive pH result were randomized to esomeprazole or randomized to budesonide, if
there was a negative pH result. Studies were interpreted by a single gastroenterologist
experienced in reading esophageal pH studies. The percent time the pH monitor detected a pH
less than 4 was recorded and an esophageal pH of less than 4 for 4% or greater of the study
time was considered abnormal. Note: pH is a measure of acidity or alkalinity (lower numbers
are more acid, higher numbers are more alkaline).

Those subjects with GERD (positive pH result) received gastric acid-suppressing medication
(esomeprazole 40 mg, twice daily) for 6 weeks. Subjects who did not have GERD (negative pH
result) were treated with a corticosteroid designed to coat the esophagus (budesonide
suspension 1 mg twice daily) for six weeks. Response to treatment was assessed by esophageal
histology and symptoms.

Inclusion Criteria:

1. Patients ages 18-80.

2. Patients who carry the diagnosis of Eosinophilic Esophagitis (EE) based on esophageal
biopsies obtained within 18 months prior to enrollment with greater than 15
eosinophils (eos) per high power field (hpf) (400 X magnification).

3. Patients who have moderate, severe, or very severe problems swallowing.

Exclusion Criteria:

1. Patients who are currently being treated for EE.

2. Patients who have used topical or systemic corticosteroid therapy for any reason over
the past 4 weeks.

3. Patients who have been treated with acid-suppressing medications (Proton Pump
Inhibitor or H2 receptor antagonists) within 4 weeks prior to enrollment.

4. Patients with known allergies or hypersensitivity to proton-pump inhibitors or
corticosteroids.

5. Patients who have contraindications to the procurement of biopsies including patients
how have known bleeding disorders, a history of bleeding diathesis, or who are
currently using warfarin or clopidogrel.

6. Patients who have a contraindication to the performance of an
esophagogastroduodenoscopy (EGD) including previous cardiopulmonary arrest during an
endoscopic procedure.

7. Patients who have contraindications to the performance of ambulatory impedance
24-hour pH testing including patients with oropharyngeal abnormalities that would
prohibit the safe passage of the transnasal catheter and patients who are currently
using warfarin, have a history of bleeding disorders or bleeding diatheses.

8. Patients who are pregnant.