Eosinophilic Esophagitis (EoE) Clinical Trial
Official title:
Six Food vs One Food Eosinophilic Esophagitis Elimination Diet (SOFEED) Followed by Swallowed Glucocorticoid Trial
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 6-food elimination diet (6FED, milk, egg, wheat, soy, tree nut/peanuts, and fish/shellfish). 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 6FED.
Participants will remain on the assigned dietary therapy for 6 weeks. At the end of 6 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 have the option to continue
into Phase 2 of the study. During Phase 2, participants who were on 1FED in Phase 1 will
receive 6FED therapy for 6 weeks, and participants who were on 6FED during Phase 1 will
receive swallowed glucocorticoid (SGC) therapy for 6 weeks. At the end of 6 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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