ulcerative colitis, colitis ulcerosa, IBD
Conditions
Interventions
Arm 1: Patients will be treated with faecal transplantation, processed for duodenal-tube infusion
Arm 2: Patients will be treated with their own faeces (placebo), processed for duodenal-tube infusion.
Sponsors
Academic Medical Center (AMC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients 18 years or older; 2. Established ulcerative colitis with known involvement of the left colon; 2. Simpe Clinial Colitis Activity Index of > 4 and 1; 4. In case of use of medication: Stable dose of thiopurines, 5-ASA, or corticosteroids in preceding 8 weeks.
Exclusion criteria
Exclusion criteria: 1. Condition leading to profound immunosuppression; 2. Anti-TNF treatment in preceding 2 mths; 3. Ciclosporine treatment in preceding 4 wks; 4. Use of Methotrexaat in preceding 2 mths; 5. Prednisolone dose > 10 mg; 6. Life expectancy 1/2 of the colon), presence of a pouch due to surgery, presence of stoma; 11. Known intra-abdominal fistula; 12. Pregnancy or women who give brestfeeding; 13. Vasopressive medication, icu stay; 14. Signs of ileus, diminished passage; 15. Allergy to macrogol or substituents, eg peanuts, shellfish.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary endpoint of clinical remission, as well as reduction of Mayo endoscopic inflammation score at 12 weeks after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. SCCAI score reduction at t=6 weeks; 2. intra individual changes in faecal samples and mucosal biopsies; 3. Frequency of bowel movements; 4. Time to recurrence. | — |
Contacts
Public ContactN.G.M. Rossen
Dept. Gastroenterology & Hepatology Academic Medical Center Amsterdam Meibergdreef 9, C2-231
Outcome results
None listed