Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 26 April 2021
• Main ID: NCT02201693
• Date of registration: 17/07/2014
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease CD-HOPE
• Scientific title: Randomised Trial Comparing 12 Months of Cyclic Enteral Nutrition to Supplementary Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease
• Date of first enrolment: December 12, 2014
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02201693
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Franck RUEMMELE, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

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



Age minimum: 6 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Dietary Supplement: MODULEN IBD

Primary Outcome(s)

The first relapse [Time Frame: 12 months]

Secondary Outcome(s)

Variation of wPCDAI, [Time Frame: until month12]

Calprotectin [Time Frame: until month12]

Transmural healing [Time Frame: Month 12]

Growth pattern [Time Frame: Until Month 12]

Time to the first relapse [Time Frame: until month 12]

Endoscopic remission [Time Frame: month 12]

Quality of life analysis [Time Frame: Until Month 12]

Clinical remission [Time Frame: 12 months]

Secondary ID(s)

P130302

2013-A01473-42

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GETAID Pediatric