Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease (NCT02201693) | Clinical Trial Compass
CompletedNot Applicable
Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease
France100 participantsStarted 2014-12-12
Plain-language summary
The purpose of this study is to compare the rate of first relapse at 12 months between maintenance therapy with cyclic exclusive enteral nutrition (EEN) (at least 100% daily calories) and maintenance therapy with supplementary enteral nutritional support (25% daily calories).
Who can participate
Age range
6 Years – 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:
* 6-18 years
* Confirmed Crohn's disease (L1, L2, L3+/- L4a/b)
* new-onset disease or acute relapse treated with enteral nutrition
* responding to induction therapy with exclusive enteral nutrition with complete clinical remission at inclusion visit (wPCDAI\<12.5)
* completed cycle of induction therapy of at least 6 weeks (6-12 weeks)
* biological treatment by Remicade has to be stopped at least 8 weeks prior to inclusion
* "wash out" of corticosteroids, immunosuppressors and treatment by Humira of minimally 4 weeks prior to inclusion
* 5-ASA and derivates have to be stopped at least at screening visit
* Antibiotics must be stopped at least 2 weeks prior to inclusion
* Informed and signed consent
Exclusion Criteria:
* Patients with B2 or B3 disease behavior (intestinal/colonic stenosis (including ileo-caecal valve), intrabdominal abscess, fistulizing disease)
* Patients not in remission on induction therapy (wPCDAI\>12.5)
* Patients with isolated and severe perianal disease
* Patients requiring surgical therapy at inclusion
* Ongoing steroid medication
* Ongoing immunosuppressor or biologics therapy
* No informed consent
* Currently participating or having participated in another interventional clinical trial during the last 4 weeks prior to the beginning of this study
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.