CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 67 enrolled
Drug / intervention
Fluticasone Propionate, 800 mcg twice daily (post 4FED failure) +3 moredrug
Likely dose
Fluticasone Propionate, 800 mcg twice daily (post 4FED 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/NCT02610816
NCT02610816Phase 3Completed
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Eosinophilic Esophagitis (EoE) Intervention Trial-Randomized 1 Food Elimination vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids

Children's Hospital Medical Center, Cincinnati·interventional·Posted Nov 20, 2015·Updated Aug 27, 2018

In Brief

A Phase 3 clinical trial evaluating 1 Food Elimination Diet, 4 Food Elimination Diet, and 2 other interventions for Eosinophilic Esophagitis and Eosinophilic Gastrointestinal Disorders (EGIDs). Completed, enrolled 67 participants across 1 site.

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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEosinophilic Esophagitis, Eosinophilic Gastrointestinal Disorders (EGIDs)
CountriesUnited States
CollaboratorsPatient-Centered Outcomes Research Institute

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 20, 2015
Enrollment StartMar 21, 2016
Primary CompletionMay 16, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.6 years ago

Interventions

1 Food Elimination Dietother

Participants eliminate milk from the diet for 12 weeks

4 Food Elimination Dietother

Participants eliminate milk, egg, wheat, soy from the diet for 12 weeks

4 Food Elimination Diet (post 1FED failure)other

Participants that fail to respond to 1FED in phase 1 eliminate milk, egg, wheat, soy from the diet for 12 weeks in Phase 2

Fluticasone Propionate, 800 mcg twice daily (post 4FED failure)drug

Participants that fail to respond to 4FED in phase 1 administer swallowed glucocorticosteroids (Flovent HFA) 800 mcg twice daily for 12 weeks in Phase 2