inflammatory bowel disease Ulcerative colitis
Conditions
Interventions
One group will be treated with faecal transplantation from a healthy donor, the
other group will be treated with autologous faeces as a placebo.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age >=18 and = 2 in either the rectum or sigmoid upon screening sigmoidoscopy • Stable dose of thiopurines, 5-ASA, in preceding 8 weeks, stable budesonide use in preciding 2 weeks, prednisone use 1.5x ULN in the subgroup of PSC/UC patients
Exclusion criteria
Exclusion criteria: • Condition leading to profound immunosuppression o For example: HIV, infectious diseases leading to immunosuppression, bone marrow malignancies o Use of systemic chemotherapy o Child-Pugh B liver cirrhosis • Anti-TNF treatment in preceding 2 months Vedolizumab, tofacitinib and/or ustekinumab treatment in preceding 2 months • Cyclosporine treatment in preceding 4 weeks • Use of Methotrexate in preceding 2 months • Prednisolone dose > 15 mg/day in preceding 2 weeks • Use of topical therapy in preceding 2 weeks • Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the proportion of study subjects in clinical and endoscopic remission per adapted Mayo: stool frequency subscores (SFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of patients with a clinical response per Adapted Mayo at week 8: decrease from baseline >= 2 points and >= 30% plus a decrease in RBS >= 1 or an absolute RBS =1 point reduction in summed endoscopic Mayo score of both the rectum and sigmoid at week 8. - Proportion of patients in sustained steroid-free remission per adapated mayo at week 12: stool frequence subscore (SFS) 1 points and >30% plus a decrease in RBS >1 or an absolute RBS 1 - Proportion of patients with: o Endoscopic improvement: Endoscopic subscore of 0 or 1 at week 8 o Endoscopic remission: endoscopic subscore = 0 at week 8 o Histological Remission: Geboes score of | — |
Countries
Netherlands
Outcome results
None listed