Transfer of Feces in Ulcerative Colitis 2 (TURN2)
Ulcerative Colitis, Ulcerative Colitis Flare, Ulcerative Colitis Acute
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria: Age ≥18 and <70 Ability to give informed consent Established ulcerative colitis with known involvement of the left colon according to the Lennard-Jones criteria Partial mayo score of ≥ 3 and calprotectin > 250 Full Mayo score 5-9 Endoscopic Mayo score of ≥2 in either the rectum or sigmoid upon screening sigmoidoscopy Stable dose of thiopurines or , 5-ASA, or budesonide in preceding 8 weeks. Stable dose of budesonide in preceding 2 weeks. Prednisone use ≤15mg/day in preceding 2 weeks with a mandatory taper of 5 mg per week starting from week 4. Women need to use reliable contraceptives during participation in the study Alkaline phosphatase > 1.5 x ULN in the subgroup of PSC/UC patients. Exclusion Criteria: Condition leading to profound immunosuppression For example: HIV, infectious diseases leading to immunosuppression, bone marrow malignancies Use of systemic chemotherapy Child-Pugh B liver cirrhosis Anti-TNFα treatment in preceding 2 months Vedolizumab treatment in preceding 2 months Tofacitinib treatment in preceding 2 months 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 < 12 months Difficulty with swallowing Use of systemic antibiotics in preceding 4 weeks Use of probiotic treatment in preceding 4 weeks Positive stool cultures for common enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic e coli) Positive C. Difficile stool test Positive dual faeces test for pathogenic parasites e.g. Dientamoeba histolytica, Giardia Lamblia, Dientamoeba fragilis, Blastocystis hominis only if microscopically many or very many blastocysts are seen. Positive serological test for HIV History of surgery: presence of a pouch presence of stoma Known intra-abdominal fistula Pregnancy or women who give breastfeeding Vasopressive medication, icu stay Signs of ileus, diminished passage Allergy to macrogol or substituents, eg peanuts, shellfish Known allergy to iv gadolinium in the subgroup of patients who would be scheduled for MRI liver Crohn's disease Subject who has any conditions that in the opinion of the investigator, would compromise the safety of the subject or the quality of the data and is an unsuitable candidate for the study
Sites / Locations
- Amsterdam University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Donor fecal microbiota transplant
Autologous fecal microbiota transplant