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NCT02610816 · ClinicalTrials.gov registry record · Phase 2
Eosinophilic Esophagitis Intervention Trial-1 Food vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids
A Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
NCT02610816: Completed Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT02610816 is a Phase 2 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 67 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02610816, a Phase 2 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
Study 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.
Primary Outcome
The PEESS V2.0 questionnaire captures EoE-specific symptoms (dysphagia, gastro-esophageal reflux disease (GERD), nausea/vomiting, and pain) as reported by children with EoE (8-18 years of age) and their parents (for children 2-18 years of age). The range for PEESS v2.0 scores is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms. Scores were obtained at baseline and 12 weeks. Change in score is defined as total score at 12 weeks minus total score at baseline.
Interventions
- OTHER 1 Food Elimination Diet
- OTHER 4 Food Elimination Diet
- OTHER 4 Food Elimination Diet (post 1FED failure)
- DRUG Fluticasone Propionate, 800 mcg twice daily (post 4FED failure)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2016-03-21 |
| Est. Completion | 2018-05-16 |
| Phase | Phase 2 |
What the finished NCT02610816 record still lists
NCT02610816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 4 interventions - of which 1 Food Elimination Diet is the first listed.
NCT02610816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02610816 about?
NCT02610816 is a clinical study titled "Eosinophilic Esophagitis Intervention Trial-1 Food vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids". 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...
What is the current status of trial NCT02610816?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2016-03-21. Estimated completion is 2018-05-16.
What interventions are being tested in trial NCT02610816?
The interventions under investigation include: 1 Food Elimination Diet (OTHER), 4 Food Elimination Diet (OTHER), 4 Food Elimination Diet (post 1FED failure) (OTHER), Fluticasone Propionate, 800 mcg twice daily (post 4FED failure) (DRUG).
Who is sponsoring clinical trial NCT02610816?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02610816's enrollment target sits among peer trials
67 974th of 2000 higher than 1,026 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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