Eosinophilic Esophagitis Intervention Trial-1 Food vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids

This study will consist of two phases, plus a screening period. During the screening period,
subject eligibility for the study will be determined. During Phase 1, qualified participants
will be randomly assigned to one of two elimination diet therapies--the 1FED or the 4FED.
Participants will remain on the assigned dietary therapy for 12 weeks. At the end of 12 weeks
of therapy, esophageal biopsies from participant's standard of care (i.e. normal, routine
care) endoscopy will be evaluated to determine disease status. Participants whose EoE is in
remission (i.e. <15 eos/hpf) will be done with the study.

Participants whose EoE is still active (i.e. ≥15 eos/hpf) will continue into Phase 2 of the
study. During Phase 2, participants who were on 1FED in Phase 1 will receive 4FED therapy for
12 weeks, and participants who were on 4FED during Phase 1 will receive swallowed
glucocorticoid therapy for 12 weeks. At the end of 12 weeks of therapy, esophageal biopsies
from participant's standard of care (i.e. normal, routine care) endoscopy will be evaluated
to determine disease status.

Inclusion Criteria:

- Have diagnosis of EoE (based on consensus criteria)

- Are aged 6 to 17 years

- Have histologically confirmed active disease >15 eosinophils/hpf in either distal or
proximal esophagus within 12 weeks of screening visit

- Proton Pump Inhibitor (PPI) confirmation

- Symptomatic (have experienced symptoms within the last month prior to enrollment)

- Has a negative urine pregnancy test at screening if of childbearing potential. Females
of childbearing potential must have a negative urine pregnancy test (β-hCG) prior to
enrollment into the study (i.e., at screening). Subsequently, these participants must
agree to use adequate birth control measures (e.g., condom,
oral/injectable/subcutaneous contraceptives, intrauterine device, or sexual
abstinence) during the study and for at least one month after the last dose of study
drug which will be documented in the source documents.

Exclusion Criteria:

- Have been treated with topical swallowed steroids within the last 2 months or systemic
steroids within the past 3 months

- Have eosinophilia in segments of the GI tract other than the esophagus

- Have been diagnosed with a GI malabsorption disorder (i.e., Inflammatory bowel
disease, Crohn's disease) or Celiac disease

- Are currently on dietary therapy avoiding milk

- Have concurrent H pylori gastritis or parasitic infection

- Are unable to obtain esophagogastroduodenoscopy with esophageal biopsies at Cincinnati
Children's Hospital Medical Center (CCHMC) or other participating institution within 4
weeks of study completion

- Have previously failed (in a clinical trial setting) dietary therapy with one of these
regimens or topical steroid treatment with fluticasone at a total dose of 1760 mcg per
day.

- Have definitely responded (in a clinical trial setting) to either dietary therapy
avoiding these antigens or to swallowed fluticasone at a total dose of 1760 mcg per
day

- Are concurrently receiving any of the prohibited medications listed in Table 2

- On immunotherapy for pollen (if not on maintenance therapy) or immunoglobulin E
(IgE)-mediated food allergy.