SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study (NCT02778867) | Clinical Trial Compass
CompletedPhase 2/3
SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study
United States129 participantsStarted 2016-05-20
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have diagnosis of EoE (based on consensus criteria)
* Have histologically confirmed active disease \>15 eosinophils/hpf in either distal or proximal esophagus within 12 weeks of screening visit
* Symptomatic (have experienced symptoms within the last month prior to enrollment)
* Proton pump inhibitor (PPI) confirmation
* Have a negative urine pregnancy test at screening if of childbearing potential
Exclusion Criteria:
* Have been treated with topical swallowed steroids within the last 2 months or systemic steroids within the last 3 months
* Have pathological eosinophilia in segments of the GI tract other than the esophagus determined by local review
* Have been diagnosed with a GI malabsorption disorder (i.e., Inflammatory bowel disease, Crohn's disease) or Celiac disease
* Are currently on dietary therapy strictly avoiding milk or on a 6FED
* Have concurrent H pylori gastritis or parasitic infection
* Have history of anaphylaxis to milk (with current avoidance of milk)
* Have previously failed strict dietary therapy clearly documented with one of these regimens or topical steroid treatment (i.e. have achieved histological remission of \<15 eos/hpf after having been on fluticasone or \>1mg budesonide per day).
* Use of investigational drugs within 4 weeks (one month) prior to enrollment
* Are concurrently receiving any of the prohibited medications for the study
* On immunotherapy for pollen (if not on maintenance therapy) or immunoglobulin-E (IgE) -m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent of Participants in Histologic Remission (<15 Eos/Hpf)
Timeframe: 6 weeks after starting treatment
Trial details
NCT IDNCT02778867
SponsorChildren's Hospital Medical Center, Cincinnati