inflammatory bowel disease ulcerative colitis
Conditions
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 produce
Sponsors
Haaglanden Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: patients > 18 years old (n
Exclusion criteria
Exclusion criteria: amongst others: pregnancy, need for (continuous) antibiotic treatment, previous prednisolon or budenofalk resistant inflammation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is engraftment of donor microbiota at 1,2, 4 and 8 weeks after the last FMT in patients pre-treated with budesonide or placebo assessed with metagenomics/deep sequencing of the gut microbiota. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints a. clinical response at 4 and 8 weeks after FMT b. donor dependent efficacy c. safety - Partial response is defined as reduction of disease activity at 4 weeks and 8 weeks after the 4th donor feces infusion. - Activity is defined as the occurrence (or recurrence) of symptoms in combination with increasing fecal calprotectin levels and distinctive radiological or endoscopic findings. - Remission is defined as absence of symptoms, and at endoscopy mucosal healing or minimal focal inflammation (Mayo 0-1). - Non-response (failure) is described as absence of response. - Sigmoidoscopy will be performed at 8 weeks after the 4th FMT (t=13 weeks), or earlier in case of clinical suspicion of persistent or recurrent activity. - In addition, salivary samples of patients will be studied for microbiota composition and comparison to gut microbiota composition. | — |
Countries
Netherlands
Outcome results
None listed