primary sclerosing cholangitis primary sclerosing cholangitis
Conditions
Interventions
Study subjects will receive 2 duodenal infusions with 200 ml of diluted donor feces via a duodenal Cortrak tube at week 1 and week 4 and 4 times an enema with 200 ml of diluted donor feces at week 1,
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - PSC according to EASL criteria- UC according to ECCO criteria.- alkaline phosphatase (ALP) >1.5x ULN- age >18 - <65 year- stable dose of thiopurines, 5-ASA, or budesonide in preceding 8 weeks- no use of UDCA or fibrates in preceding 4 weeks- Fibroscan < 9.6 kPa with IQR <15%- Amsterdam-Oxford score = 2
Exclusion criteria
Exclusion criteria: - full Mayo score >8- inability to give informed consent- positive stool culture for pathogen- condition leading to severe immunosuppression- exposure to biologicals, small molecules, methotrexate, antibiotics, or steroids in previous 8 weeks- previous bowel surgery- evidence of colonic neoplasia upon screening colonoscopy max. 6 months prior to enrolment- current smoking- use of proton pump inhibitors, metformin, or SSRIs in the previous 8 weeks- claustrophobia- Difficulty with swallowing- Pregnancy or women who give breastfeeding - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main outcome: Primary endpoint at week 8 is a composite of decrease in Alkaline Phosphatase >25%, decrease in cT1 on liver multiscan > 82 ms (Alkhouri et al J Hep 2024), and decrease in enhanced Liver Fibrosis (ELF) test of > 0.44 point (recent own data). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change on group level of ALP, IgG, Amsterdam-Oxford score, cT1, ELF, pro-C3, fecal calprotectinCompositional changes of fecal microbiota (bacterial networks, bacteria-phage interactions) by metagenome sequencing.Changes in metabolic fecal output with an emphasis of bile acid metabolism and short chain fatty acids.Change in Simple Cholestatic Complaints Score (SCCS) (20)Change in Simple Clinical Colitis Activity Index (SCCAI) Groningen IBD Nutritional Questionnaire for check on stable dietChange in 5D-Itch score | — |
Countries
Netherlands
Contacts
Public ContactC.Y. Ponsioen
Amsterdam UMC
Outcome results
None listed