chronic bowel inflammation Inflammatory Bowel Disease (IBD)
Conditions
Interventions
1. RCT: CDED phase 3 (maintenance phase) for patients after remission with CDED
phase 1 and 2 as induction of remission or as adjuvant concomitant treatment
(to ongoing standard of care stable treat
Sponsors
Amsterdam UMC
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for entering study at week 0: 1. Male or female, children >=10 years old or adults = 250 microgram/g within 30 days prior to week 0 visit 4. Provision of signed and dated informed consent form with stated willingness to comply with all study procedures and availability for the duration of the study Inclusion criteria for entering the RCT (maintenance phase) of the study (weeks 12-24): 1. Corticosteroid-free clinical remission a. HBI
Exclusion criteria
Exclusion criteria: 1. Stricturing, penetrating (intestinal or perianal) and/or fistulising disease, specifically symptoms of stenosis/sub-obstruction or radiological evidence of significant stenosis (pre-stenotic dilatation) which renders the use of CDED contraindicated 2. Inflammation limited to the rectum (proctitis) 3. Inflammation limited to intestinal segments proximal to the terminal ileum 4. Having undergone intestinal resection 5. Laboratory diagnosis of Clostridium Difficile Infection (CDI) or any other infections (SSYC), if performed for clinical indication 6. Pregnancy/lactation 7. Dual biologic therapy 8. Biologic dose escalation within previous 6 weeks 9. Present or past history of eating disorder including anorexia nervosa 10. Adhering to a vegan diet Patients with known pre-existing conditions that may affect HRV (e.g. (congenital) heart disease or use of anti-arrhythmic drugs, other inflammatory conditions (such as SLE, JIA) and anxiety disorders), will not be offered the observational HRV measurements but can join the study without HRV measurement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will assess a composite outcome of steroid-free clinical remission as Harvey Bradshaw Index (HBI) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Composite outcome + normal CRP at week 24 2. IUS response at week 6, 12, 24 3. IUS remission at week 6, 12, 24 4. Composite steroid-free clinical remission + calprotectin response + intestinal ultrasound (IUS) response at week 24 5. Composite steroid-free clinical remission + calprotectin response + intestinal ultrasound (IUS) response + normal CRP at week 24 6. (Primary) non-response to dietary therapy at week 6 and loss of response at weeks 12, 16, 24 (with good compliance) 7. Survival analysis of loss of remission during CDED phase 3 versus normal diet, based on HBI and biweekly calprotectin measurements (week 12, 14, 16, 18, 20, 22, 24) 8. Clinical remission (HBI | — |
Countries
Netherlands
Outcome results
None listed