Eosinophilic Esophagitis Clinical Therapy Comparison Trial

• Quality of Life [ Time Frame: 16 weeks ]
  PedsQL to assess overall quality of life.
• Symptom score [ Time Frame: 16 weeks ]
  Assess the subject's symptoms using the validated tool termed Pediatric Eosinophilic Esophagitis (EoE) Symptom Severity Module by measuring % of normal bolus transit swallow and % of normal peristaltic esophageal body contractions.
• Exploratory studies [ Time Frame: Conclusion of study ]
  Proteomic studies search for certain proteins in the blood that may be linked to active EoE. Immune analysis will help identify better methods for diagnosis, treatment, and prevention of immune system changes leading to diseases.

• Quality of Life [ Time Frame: 8 weeks ]
  PedsQL to assess overall quality of life.
• Symptom score [ Time Frame: 8 weeks ]
  Assess the subject's symptoms using the validated tool termed Pediatric Eosinophilic Esophagitis (EoE) Symptom Severity Module by measuring % of normal bolus transit swallow and % of normal peristaltic esophageal body contractions.
• Exploratory Proteomic and immune analysis [ Time Frame: 8 weeks ]
  Proteomic studies search for certain proteins in the blood that may be linked to active EoE. Immune analysis will help identify better methods for diagnosis, treatment, and prevention of immune system changes leading to diseases.

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."

This study is a open label, randomized, prospective clinical trial comparing the efficacy of a topical steroid preparation to an antigen (food) elimination diet.

A total of 60 participants will be recruited for this study that are positive for food allergens. Study participants will be randomly assigned to treatments as described below, and the duration of each treatment phase will be 16 weeks.

The subjects will be randomized to group A and B. Subject and study team will NOT be blinded to the group assignments.

Group A will receive oral viscous budesonide at a dose of 1 or 2 mg daily depending on the height.

Group B will receive an elimination diet (elimination of the foods the subject is allergic to).

• Drug: Oral Budesonide
  This group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day
  Other Name: Steroid
• Other: Elimination diet
  This group will receive an elimination diet

• Active Comparator: Positive for food allergy: Group A
  Oral Budesonide
  Intervention: Drug: Oral Budesonide
• Active Comparator: Positive for food allergy: Group B
  Elimination diet
  Intervention: Other: Elimination diet

Inclusion:

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