Diet for Induction and Maintenance of Remission and Re-biosis in Crohn's disease
- Conditions
- Crohn's Disease
- Registration Number
- NL-OMON23154
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
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
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 <8 weeks, or dose change in past 8 weeks.
7. Patients with past or current use of biologics, or patients who currently use systemic steroids or used steroids over the last 8 weeks
8. Patients who have active perianal disease (active fistula or abscess)
9. Patients who have positive stool cultures with relevant pathogens, or positive tests for parasites or C. difficile. Stool tests are mandatory only if diarrhea is present.
10. Patients with fever > 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. ITT steroid-free clinical remission at week 8<br>2. Microbiome composition difference between groups at week 14<br>3. Reduction of at least 50% from baseline in fecal calprotectin at week 24 for patients who did not change their treatment<br>4. Steroid and biologic free remission at week 24.<br>5. Need for additional treatment to achieve remission by week 14<br>6. Transmural healing as assessed by MRE in dietary responsive disease at week 52<br>7. The proportion of patients who respond with the susceptible genes compare to those without the susceptible genes<br>8. Microbiome composition difference between dietary responders to healthy controls at week 24