Eosinophilic Esophagitis Clinical Therapy Comparison Trial
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: Oral Budesonide; Elimination diet
Intervention description: This group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day; This group will receive an elimination diet
Intervention MeSH terms: Budesonide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Eosinophil; Reflux; Esophagus; Food allergy; Trouble Swallowing; Pediatrics

Summary:

      Eosinophilic Esophagitis (EoE) is a disorder in which a type of white blood cell (eosinophil)
      involved in allergic reactions, enter and cover the walls of the esophagus (food pipe). As a
      result, the esophagus becomes swollen and blocked making it difficult to swallow, and this
      leads to heartburn. In severe cases it can lead to food getting stuck in the esophagus and
      poor growth or weight loss in children

      The main purpose of this research study is to compare the effectiveness of two different
      types of treatment for EoE:

        1. Oral viscous budesonide- which is a steroid medication that has been used to treat
           asthma. Recently, it has been used as a therapy to treat the eosinophilic inflammation
           in EoE, and

        2. Specific food elimination.

      The study will also be looking to see if a blood test is useful in following the progression
      of EoE. Currently the only way to follow EoE is by repeating endoscopy, which is a more
      "invasive test."
    

Eligibility criteria:

        Inclusion Criteria

          1. Signed written informed consent and assent if applicable prior to performing any study
             specific procedure.

          2. Male or female subjects aged 3-17 years old.

          3. Diagnosis of EoE within 2 months of enrollment (greater than or equal to 15
             eosinophils per high powered field in both proximal or distal esophageal specimens).

          4. Subjects who have failed at least a two month trial of proton pump inhibitor.

          5. A female subject of childbearing potential who is or may become sexually active agrees
             to routinely use contraception from the time of signing informed consent and assent
             until 30 days from end of study.

          6. Positive allergy testing on prick and/or patch testing.

        Exclusion Criteria

          1. Subjects who are responsive to at least a two month trial of a proton pump inhibitor.

          2. Diagnosis of Inflammatory Bowel Disease or static encephalopathy.

          3. Prior abdominal surgery and other organ disorder not including atopic diseases.

          4. Previous esophageal surgical procedure.

          5. Previous esophageal congenital disorders such as tracheal esophageal fistula and
             esophageal atresia.

          6. Positive for pregnancy.

          7. Previous therapy within 6 weeks with oral or swallowed steroids or strict dietary
             elimination of major allergens

          8. Presence of increased eosinophils in the stomach, small intestine, large intestine,
             and colon based on Debrosse et al.