CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 129 enrolled
Drug / intervention
Fluticasone Propionate, 880 mcg twice daily (after 6FED failure) +3 moredrug
Likely dose
Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02778867
NCT02778867Phase 3Completed

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

Children's Hospital Medical Center, Cincinnati·interventional·Posted May 20, 2016·Updated May 26, 2020

In Brief

A Phase 3 clinical trial evaluating 1 Food Elimination Diet Therapy, 6 Food Elimination Diet Therapy, and 2 other interventions for Eosinophilic Gastrointestinal Disorders (EGIDs) and Eosinophilic Esophagitis (EoE). Completed, enrolled 129 participants across 9 sites.

Detailed 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.

Study Details

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 20, 2016
Enrollment StartMay 20, 2016
Primary CompletionApr 17, 2019
Study CompletionMay 29, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.1 years ago

Interventions

1 Food Elimination Diet Therapyother

6 Food Elimination Diet Therapyother

6 Food Elimination Diet (after 1FED failure)other

Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)drug