| Interventions |
Intervention Patients with active ulcerative colitis (n=24) will be randomized to a 3 weeks course of budesonide 9 mg once a day or placebo, followed by 4 infusions of a donor feces solution produced by the NDFB. The first FMT will be scheduled immediately after cessation of budesonide or placebo (t=3 weeks) and is delivered by a nasoduodenal tube. Three subsequent FMTs are scheduled weekly. Each individual patient receives donor feces infusion of one donor. Patients are treated with bowel lavage one day prior to the first FMT. Bowel lavage is not given prior to the 2nd, 3rd and 4th FMT. Sigmoidoscopy will be performed 8 weeks after the 4th FMT, or earlier in case of clinical suspicion of persistent or recurrent activity. Randomized studies suggest a donor dependent effect of FMT. Initially, two donors will be selected (donor A and donor B), and patients are randomized to receive donor feces suspensions from either donor A or donor B. Previous randomized controlled trials have shown modest effectivity of FMT in patients with active ulcerative colitis using different treatment schedules with 3; 6 and 40 (repeated) infusions of donor feces suspensions (1-3). The study which offered only three infusions of donor feces did not show a statistically significant improvement (2). Therefore, the current study protocol consists of 4 infusions of donor feces suspensions after short induction treatment with budesonide Donor selection: Donors are healthy volunteers, carefully selected by the Netherlands Donor Feces Bank (5). Donor screening consists of questionnaires addressing potential risk factors for transmittable diseases, and risk factors for diseases associated with a dis |