NCT02778867

SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study

Six Food vs One Food Eosinophilic Esophagitis Elimination Diet (SOFEED) Followed by Swallowed Glucocorticoid Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Eosinophilic Gastrointestinal Disorders (EGIDs)
• Eosinophilic Esophagitis (EoE)

Interventions

Type	Name	Description
OTHER	1 Food Elimination Diet Therapy
OTHER	6 Food Elimination Diet Therapy
OTHER	6 Food Elimination Diet (after 1FED failure)
DRUG	Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)

Timeline

• Start date: 2016-05-20
• Primary completion: 2019-04-17
• Completion: 2019-05-29
• First posted: 2016-05-20
• Last updated: 2020-05-26
• Results posted: 2020-05-26

Locations

9 sites across 1 country: United States