Eosinophilic Esophagitis Clinical Trial
Official title:
Eosinophilic Esophagitis (EoE) Intervention Trial-Randomized 1 Food Elimination vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids
The purpose of this interventional study is to test and compare the effectiveness of two elimination diets—the 1-food elimination diet (1FED, milk only) and the 4-food elimination diet (4FED, milk, egg, wheat, and soy) for eosinophilic esophagitis (EoE). The study will also test the effectiveness of swallowed glucocorticoid therapy in some of the study participants for whom diet therapy was not effective.
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.
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