A Prospective Study of the Four Food Elimination Diet for Treatment of Eosinophilic Esophagitis (NCT05176262) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Prospective Study of the Four Food Elimination Diet for Treatment of Eosinophilic Esophagitis
United States64 participantsStarted 2011-07
Plain-language summary
This study is to observe the efficacy of the four food elimination diet.
Who can participate
Age range
1 Year – 18 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:
* Patients ages 12 months-18 years
* Presence of clinical symptoms related to esophageal dysfunction such as: feeding aversion, failure to thrive, vomiting, abdominal pain, dysphagia, heartburn, and food impaction
* Histologic criteria for the diagnosis of EoE with ≥15 eosinophils per high power field from review of a total of six biopsies obtained from the distal and mid (three from each site) esophagus in subjects who were adequately pre-treated with a proton-pump inhibitor- 1mg/kg/dose twice daily, up to a maximum of 40mg or 30mg per dose depending on preparation for 6-8 weeks or had a normal 24 hour ph probe study18
* Patients who agree to 4-FED as their treatment of EoE
Exclusion criteria:
* Those patients who are on oral or swallowed steroids (prior use of steroids that was discontinued more than two months prior to enrollment does not constitute an exclusion criterion)
* Patients who are unable to tolerate the 4-FED
* Patients with concurrent eosinophilic gastroenteritis or eosinophilic colitis
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
Efficacy of the Four Food Elimination Diet
Timeframe: every 6-12 months, at standard of score endoscopies
Trial details
NCT IDNCT05176262
SponsorAnn & Robert H Lurie Children's Hospital of Chicago