Primary Sclerosing Cholangitis (PSC) is a rare cholestatic liver disease, commonly associated with inflammatory bowel disease (IBD) The aim of the present trial is to assess the efficacy of fecal microbiota transplantation (FMT) on ALP and bilirubin compared to sham transplantation in addition to ursodeoxycholic acid (UDCA) treatment in PSC patients.
Males or females
Age ≥18 and ≤75 years
Large duct PSC verified by retrograde, operative, percutaneous or magnetic resonance cholangiography (MRC) demonstrating intrahepatic and /or extrahepatic biliary duct changes consistent with PSC
IBD diagnosed according to international guidelines (presence of endoscopic and histologic signs)
Small duct PSC
Autoimmune hepatitis defined by the presence of moderate to severe interface hepatitis documented on liver biopsy and at least 1 of the 2 following criteria: AST or ALT > 5 ULN, Positive anti smooth muscle auto antibodies or serum IgG > 1.5 ULN
Secondary sclerosing cholangitis (notably IgG4-associated cholangitis)
Cirrhosis defined by Liver elastometry >14.4 kPa or by current or past decompensation of cirrhosis
Parallel
Fecal microbiota transplantation (FMT)
DrugOne to 4 weeks after randomization, the patient will be hospitalized in one of the hepato-gastroenterology department involved in the study for the colonoscopy. The patient will then receive either FMT (suspension of 50g of stools in 300ml of cryopreservative solution) in the terminal ileum or the caecum. At W12 and W24 after first colonoscopy , the patient will receive orally 20 FMT (capsules swallowed in front of a physician or a nurse in hospital)
Sham-transplantation (placebo)
DrugOne to 4 weeks after randomization, the patient will be hospitalized in one of the hepato-gastroenterology department involved in the study for the colonoscopy. The patient will then receive sham transplantation (FMT vehicle, i.e. 300ml of cryopreservative solution) in the terminal ileum or the caecum. At W12 and W24 after first colonoscopy , the patient will receive orally 20 sham capsules (capsules swallowed in front of a physician or a nurse in hospital)
To assess in patients with PSC the efficacy of FMT versus sham transplantation on ALP and bilirubin at week 48 addition to standard UDCA therapy.
Proportion of success at week 48. Success is defined as patients with serum ALP \<1.3 ULN at week 48 and a reduction of, at least 15%, compared to baseline ALP level AND normal total bilirubin ≤ 1 ULN at week 48
Efficacy of FMT on reduction of ALP and normalization of bilirubin level at week 12, 24, 36 and 48 individually
Proportion of success at week 12, 24 , 36 and 48. Success is defined as patients with serum ALP \<1.3 ULN and a reduction of, at least 15%, compared to baseline ALP level AND normal total bilirubin ≤ 1 ULN
Efficacy of FMT on biochemical liver tests at week 12, 24, 36 and 48 (ALP, GGT, AST, ALT and bilirubin)
Proportion of patients that normalized all liver tests (ALP \<1ULN and GGT \<1 ULN and AST \<1 ULN and ALT \<1 ULN and total bilirubin \<1 ULN) at week 12 24 36 and 48
Efficacy of FMT on liver fibrosis progression
assessed by transient elastography at week 48 versus week 0
PSC prognostic scores
PSC Prognostic scores including the MELD score, the Revised PSC Mayo Risk Score, the Amsterdam-Oxford prognostic model (week 0, week 48)
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