The Immune Directed Individualized Elimination Therapy (iDIET) Study (NCT05543512) | Clinical Trial Compass
CompletedNot Applicable
The Immune Directed Individualized Elimination Therapy (iDIET) Study
United States56 participantsStarted 2022-10-14
Plain-language summary
This is a randomized, double blind, sham-controlled, pilot/feasibility trial of individualized dietary elimination treatment.
Who can participate
Age range
16 Years – 80 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:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Age: 16 - 80 years
* Diagnosis of EoE as per consensus guidelines
* No prior treatment with, or documented failure of, dietary elimination therapy. Failure is defined as =\>15 eos/hpf after a course of the six-food elimination diet (SFED).
* On stable diet for 4 weeks prior to screening endoscopy and agree to maintain throughout course of participation. Foods eliminated for allergic or other reactions are not exclusionary and may continue to be avoided throughout participation in the study regardless of food trigger results.
In addition to meeting the above criteria, to be eligible for randomization an individual must meet all of the following criteria:
* Active EoE (=\>15 eos/hpf) based on clinical biopsies taken during baseline endoscopy
* Must have at least one positive food on the IgG4 or T cell stimulation assay
Exclusion Criteria:
* Concomitant eosinophilic gastritis and/or enteritis, confirmed with a prior clinicohistologic diagnosis
* Use of systemic corticosteroids within 4 weeks of the baseline/qualifying endoscopic exam
* Previous esophageal resection
* History of bleeding disorder or esophageal varices
* Current use of blood thinners such as coumadin, warfarin, heparin, and/or novel anticoagulant agents (requires discontinuation of medication within an appropriate time frame for that specific agent and in accordance with standard…
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.