Crohn's Disease
Conditions
Interventions
Modified CDED
Sponsors
Amsterdam UMC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Established diagnosis of Crohn's disease. 2. Patients with mild to severe active Crohn's disease (15=PCDAI=47.5) 3. Ages 8-18 4. Duration of disease = 36 months 5. Active inflammation (CRP=0.6 mg/dL or ESR=20 or Calprotectin=200 mcg/gr during screening 6. Patients with B1, P0 uncomplicated disease at enrollment 7. Patients with disease defined as L1, L4, L3 or L2 limited to cecum, ascending or transverse colon or L2 with leftsided disease with terminal ileum or small bowel involvement in the past by the Paris classification (patients with macroscopic disease) 8. Signed informed consent Inclusion criteria comments: 1. Patients with stable medication (IMM/5ASA) use or no medication use for the past 2. Patients with few aphthous ulcers in the rectosigmoid only can be enrolled as L2
Exclusion criteria
Exclusion criteria: 1. Patients with very mild disease (PCDAI 12.5-15) or very severe disease (PCDAI >47.5) 2. Pregnancy 3. Patients who have disease confined to the colon involving the descending colon, rectum or sigmoid colon and no prior history of small bowel involvement 4. Patients who have active extra intestinal disease (such as arthritis, uveitis, pyoderma gangresom, erythemanodosum, etc.) 5. Patients with complicated disease (B2, B3) 6. Patients with recent onset use of an immunomodulator 38.3 11. Documented milk protein allergy Exclusion criteria comments: 1. Aphthous stomatitis is not an exclusion criterion. Isolated aphthous ulcers of the rectosigmoid need not be excluded as left sided L2 only 2. Patient may receive a stable dose immunomodulator or start thiopurines at or after week 4 or Methotrexate at week 6, since the effect of thiopurine starts after 8 weeks and that does not affect the primary endpoint remission at week 8. 3. Patients are allowed use of Omeprazole if ulcers or erosions are present in the stomach or duodenum. 4. Patients may receive antibiotics for intercurrent infections for up to 10 days with the exception of quinolones,metronidazole, rifaximin or oral vancomycin; antibiotics used must be registered in the CRF. 5. Patients with skin tags or fissures can be enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point will be ITT, sustained Corticosteroid-free remission at week 14 (defined as Pediatric Crohn Disease Activity Index- PCDAI =10 without exposure to systemic steroids). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. ITT steroid-free clinical remission at week 8 2. Microbiome composition difference between groups at week 14 3. Reduction of at least 50% from baseline in fecal calprotectin at week 24 for patients who did not change their treatment 4. Steroid and biologic free remission at week 24. 5. Need for additional treatment to achieve remission by week 14 6. Transmural healing as assessed by MRE in dietary responsive disease at week 52 7. The proportion of patients who respond with the susceptible genes compare to those without the susceptible genes 8. Microbiome composition difference between dietary responders to healthy controls at week 24 | — |
Contacts
Public ContactCharlotte Verburgt
AmsterdamUMC
Outcome results
None listed