MedTrace Logo

Eosinophilic Esophagitis Intervention Trial-1 Food vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids

NCT02610816 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2018-08-27

Study results available
· View outcomes & findings →

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.

Conditions

  • Eosinophilic Esophagitis
  • Eosinophilic Gastrointestinal Disorders (EGIDs)

Interventions

OTHER

1 Food Elimination Diet

Participants eliminate milk from the diet for 12 weeks

OTHER

4 Food Elimination Diet

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

OTHER

4 Food Elimination Diet (post 1FED failure)

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

DRUG

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

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

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Marc E Rothenberg, MD, PhD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-21
Primary Completion
2018-05-16
Completion
2018-05-16

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02610816 on ClinicalTrials.gov