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NCT02778867 · ClinicalTrials.gov registry record · Phase 2
SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study
A Phase 2 study of Eosinophilic Esophagitis (EoE) and Eosinophilic Gastrointestinal Disorders (EGIDs), sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
- 9
- Study locations
NCT02778867: Completed Phase 2 study of Eosinophilic Esophagitis (EoE) and Eosinophilic Gastrointestinal Disorders (EGIDs), sponsored by Children's Hospital Medical Center, Cincinnati.
NCT02778867 is a Phase 2 study of Eosinophilic Esophagitis (EoE) and Eosinophilic Gastrointestinal Disorders (EGIDs) that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 129 participants, above the 113-participant average among 10 other Eosinophilic Esophagitis (EoE) trials with a reported enrollment target (14% higher). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02778867, a Phase 2 study of Eosinophilic Esophagitis (EoE) and Eosinophilic Gastrointestinal Disorders (EGIDs), has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
- 9
- Study locations
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 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.
Primary Outcome
Percent of participants in histologic remission in 1FED versus 6FED groups. Remission is defined as esophageal peak eosinophil count \< 15 eosinophils per high powered field (eos/hpf)
Conditions Studied
Interventions
- 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)
Study Locations (9)
California
- University of California, San Diego - La Jolla
Illinois
- Northwestern University - Chicago
Massachusetts
- Tufts University - Boston
Minnesota
- Mayo Clinic - Rochester
New York
- Icahn School of Medicine at Mount Sinai - New York
North Carolina
- University of North Carolina, Chapel Hill - Chapel Hill
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2016-05-20 |
| Est. Completion | 2019-05-29 |
| Phase | Phase 2 |
What the finished NCT02778867 record still lists
NCT02778867 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, above the 113-participant average among 10 other Eosinophilic Esophagitis (EoE) trials with a reported enrollment target (14% higher).
The record links to 2 conditions, with Eosinophilic Esophagitis (EoE) appearing as the primary indexed condition, and to 4 interventions - of which 1 Food Elimination Diet Therapy is the first listed.
NCT02778867 lists 9 locations in 9 states (California, Illinois, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT02778867 about?
NCT02778867 is a clinical study titled "SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study". 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 ...
What is the current status of trial NCT02778867?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2016-05-20. Estimated completion is 2019-05-29.
What conditions does trial NCT02778867 study?
This clinical trial studies the following conditions: Eosinophilic Esophagitis (EoE), Eosinophilic Gastrointestinal Disorders (EGIDs).
What interventions are being tested in trial NCT02778867?
The interventions under investigation include: 1 Food Elimination Diet Therapy (OTHER), 6 Food Elimination Diet Therapy (OTHER), 6 Food Elimination Diet (after 1FED failure) (OTHER), Fluticasone Propionate, 880 mcg twice daily (after 6FED failure) (DRUG).
Who is sponsoring clinical trial NCT02778867?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02778867 being conducted?
This trial has 9 study locations across California, Illinois, Massachusetts, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02778867's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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