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 range6 Years – 18 Years
SexALL
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