inflammation of the pouch reservoir Pouchitis
Conditions
Interventions
Patients will receive a multiple faecal microbiota transfers from healthy,
carefully selected donors.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • IPAA for ulcerative colitis • Episode of acute pouchitis, defined as a PDAI >= 7, and endoscopic subscore of > 2 • History of at least one episode of pouchitis, which necessitated antibiotic treatment.
Exclusion criteria
Exclusion criteria: - Pouchitis due to surgery related conditions (i.e. abscess, fistula. sinus of the pouch), identified by endoscopic assessment of the pouch - Crohn's Disease - Patients with signs of severe systemic inflammation (at least two of the following symptoms: temperature > 38.5 *C, tachycardia > 100 bpm (after rehydration), systolic blood pressure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the proportion of patients in clinical and endoscopic remission at week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| The main secondary endpoints are antibiotic-free clinical and endoscopic remission at week 52, and changes in microbiota signature, functional profiling as well as metabolic output from baseline to week 8 and week 52. To study the speed of clinical remission induction of pouchitis after FMT. | — |
Countries
Netherlands
Outcome results
None listed