Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
Brief Summary: Eosinophilic esophagitis (EE) is an increasingly recognized condition characterized by dysphagia, food impaction or other obstructive esophageal symptoms in children and young adults.

The pathophysiology of EE appears to be an allergy/atopy mediated disease. A personal and family history of allergic diseases (food allergies, atopic dermatitis, asthma, allergic rhinitis or conjunctivitis) has been noted in 62-85% of patients with EE. The rising incidence of EE may be related to the worldwide allergy and asthma epidemic.

Current treatment of EE is directed at decreasing esophageal allergic inflammation. Oral and topical corticosteroids, cromolyn sodium, montelukast and elemental/elimination diets have all been shown to be effective. However, none of these treatments are directed at the specific pathophysiologic mechanism of EE and some have significant side effects.

The shared pathogenetic mechanisms of EE and asthma suggest that therapeutic strategies directed at asthma may also be effective for EE. Specifically those targeted at the allergic immune mechanisms involved with asthma may be effective. Omalizumab is a recently developed anti-IgE antibody that has been shown to decrease the use of inhaled and oral corticosteroids, reduce the frequency of asthma exacerbations, and improve asthma related symptoms in patients with allergic asthma. The objective of the study is to determine the efficacy of omalizumab in the treatment of eosinophilic esophagitis


Options:
A: Inclusion Criteria:

* Histologic evidence of EoE
* Clinical symptoms of EoE including dysphagia

Exclusion Criteria:

* Primary causes of esophageal eosinophilia other than EoE
B: Inclusion Criteria:

* Histologic evidence of EE defined as greater than 20 eosinophils per hpf on esophageal biopsy
* Ages 1 yrs and older
* Ability to continue the same diet that the patient was on at the time of EGD with biopsy

Exclusion Criteria:

* Adverse reaction or allergy to budesonide
* Pregnancy
* Chronic diseases requiring immunomodulatory therapy
* Use of swallowed topical corticosteroids for EE within the past 3 months
* Use of systemic steroids 2 months prior to study entry
* Upper gastrointestinal bleed within 4 months of study entry
* Chronic use of medications that predispose to upper gastrointestinal bleeding including non-steroidal anti-inflammatory medications or anticoagulants
* Evidence of adrenal suppression prior to study entry
* Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis
* Recent changes in asthma or allergic rhinitis therapy for 3 months
C: Inclusion Criteria:

* Male or female subjects aged 12-60 years of age with EE as defined above
* Serum IgE level 30-700 IU/mL
* Subjects with acceptable medical history, physical exam and laboratory test results
* No history of bleeding diathesis, significant cardiopulmonary disease, or other contraindication to upper endoscopy

Exclusion Criteria:

* Need for esophageal dilation at enrollment due to food impaction or inability to pass endoscope
* Inability of subject to provide informed consent (if ages 18-60), or inability of children (ages 12-17) to provide assent
* History of esophagogastric surgery
* Presence of other esophageal pathology that could account for patients' symptoms including eosinophil infiltration due to gastroesophageal reflux disease (GERD)
* Incarceration
* Pregnancy
* Women of childbearing potential not using the contraception method(s)
* Patients with elevated serum IgE levels for reasons other than atopy
* Patients taking cromolyn sodium or nedocromil sodium within 1 month of visit 1
* Patients taking oral or topical corticosteroids within one month of visit 1
* Patients taking leukotriene receptor inhibitors within one month of visit 1
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
* Patients with a history of noncompliance to medical regimens or who were considered potentially unreliable
* Use of any other investigational agent in the last 30 days
* Patients with a known hypersensitivity to any ingredient of rhuMAb-E25, study rescue medication
* Patients with Barrett's esophagus will be excluded if found endoscopically or pathologically at biopsy
* Currently treated with omalizumab or treated with omalizumab within the past 6 months.
D: Inclusion Criteria:

* Diagnosis of eosinophilic esophagitis

Exclusion Criteria:

* Concomitant treatment with swallowed corticosteroids. Any prior use of swallowed corticosteroids will require a 4 week washout period.
* Pregnancy (all females of child bearing potential will have urine pregnancy test done at baseline).
* Evidence of pathologic eosinophilia in other locations in the GI tract.
* Participation in another research protocol
* Reduced Renal or Hepatic Function (all subjects will have a baseline creatinine and liver function panel drawn)

Answer: C