inflammatory bowel disease ulcerative colitis
Conditions
Interventions
Patients will be treated with faecal transplantation, processed for
duodenal-tube infusion. Faeces will be collected from a donor as well as the
patient him/herself, in which their own faeces will b
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: *Age *18 *Ability to give informed consent *Established left sided ulcerative colitis according to the Lennard-Jones criteria *SCCAI (Simple Clinical Colitis Activity Index) of 4 - 11 *Endoscopic Mayo score of >1 *Stable dose of thiopurines, 5-ASA, or corticosteroids in preceding 8 weeks *Women need to use reliable contraceptives during participation in the study
Exclusion criteria
Exclusion criteria: * condition leading to profound immunosuppression o For example: HIV, infectious diseases leading to imunosuppression, bone marrow malignancies o Use of systemic chemotherapy * Anti-TNF treatment in preceding 2 months * Ciclosporine treatment in preceding 4 weeks * Prednisolone dose * 10 mg * Life expectancy * of the colon) o presence of a pouch due to surgery o Presence of stoma * Known intra-abdominal fistula * Pregnancy or women who give brestfeeding * Vasopressive medication, icu stay * Signs of ileus, diminished passage * Allergy to macrogol or substituents, eg peanuts, shellfish
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Complete clinical remission (SCCAI 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| * Adverse events (AE) at t=3, t=6 and t=12 weeks * SCCAI score reduction at t=6 weeks (pairwise SSCAI reduction of > 1.5 points will be regarded as a relevant reduction (10)) * Frequency of bowel movements (starting to report at t= -2 weeks) * Reduction of Mayo endoscopic score at t=6 wk * Time to recurrence (recurrence is defined as a SCCAI of *4 and Mayo score *1 (10)) * Intra individual changes in presence of microbial DNA in faecal samples at t=0, t=6, and t=12 weeks after faecal transplantation. * Intra individual changes in presence of microbial DNA in mucosal biopsies at t=0, t=6, and t=12 weeks after faecal transplantation. | — |
Countries
Netherlands
Outcome results
None listed