Ulcerative colitis, colitis ulcerosa, IBD, Primary Sclerosing Cholangitis
Conditions
Interventions
Arm 1: Patients will be treated with faecal transplantation, processed for duodenal and rectal administration.
Arm 2: Patients will be treated with their own faeces (placebo), processed for duodenal a
Sponsors
Academical Medical Center (AMC)
Eligibility
Inclusion criteria
Inclusion criteria: • Age =18 and 250 • Full Mayo score 5-9 • Endoscopic Mayo score of ?2 in either the rectum or sigmoid upon screening sigmoidoscopy • Stable dose of thiopurines, 5-ASA, or budesonide in preceding 8 weeks, prednisone use =15mg/day in preceding 2 weeks, stable dose of 5-ASA or corticosteroid containing enemas in preceding 2 weeks • 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
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-TNF 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 • 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 • Known allergy to iv gadolinium in the subgroup of patients who would be scheduled for MRI liver
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) = 1, rectal bleeding subscore (RBS) =0 and endoscopic subscore = 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients with a clinical response per Adapted Mayo at week 8 2. Proportion of patients with =1 point reduction in summed endoscopic Mayo score of both the rectum and sigmoid at week 8. 3. Proportion of patients in sustained steroid-free remission per adapted mayo at week 8 4. Proportion of patients in clinical response per partial adapted Mayo (without endoscopy) at week 8 5. Proportion of patients in clinical remission per full mayo at week 8 6. Change in microbiota signature from baseline to week 2, week 8 and week 52 7. Change in IBDQ-control from baseline to week 1,2,3,4, 8,18 and week 52 8. Change in SSCAI from baseline to week 1,2,3 4,8, 18 and week 52 9. Change in MRI liver images (with post-processing analysis techniques MRCP+ and cT1) from baseline to week 8. | — |
Contacts
Public ContactMelanie Benard
Amsterdam University Medical Center - AMC
Outcome results
None listed