Status:
COMPLETED
Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
GETAID Pediatric
Conditions:
Crohn's Disease
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief 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 ...
Detailed Description
Enteral nutrition (EN) is a highly efficacious treatment option for Crohn's disease (CD). In children, exclusive EN is considered first choice therapy to induce remission in pediatric CD, as highlight...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 12 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02201693
Start Date
December 12 2014
End Date
October 2 2019
Last Update
April 14 2021
Active Locations (1)
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1
Hôpital Necker - Enfants Malades
Paris, France, 75015