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SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study
NCT02778867 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02778867
The ClinicalTrials.gov registry entry for NCT02778867 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 715 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02778867 reports 9 study locations spanning 9 distinct geographic areas — top geographies include California, Illinois, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02778867?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 715 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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