Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for PSC

Inclusion criteria

• Ages 18-76
• Serum total bilirubin at screening ≤ 2x the upper limit of normal
• Absence of biliary obstruction and malignancy by ultrasound or equivalent imaging within 6 months of study entry
• Anticipated maintenance of current medication regimen through the treatment period (UDCA, azathioprine, corticosteroid, methotrexate, 5-ASA, biologic therapy and/or probiotic)
• 3-month washout period of obeticholic acid or other experimental therapies for PSC
• Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and/or video visits or correspondence.
• Informed consent

Exclusion criteria

• Antibiotic therapy (except vancomycin) within 3 months or anticipated antibiotic use in the course of the MTT treatment
• Presence of complications of advanced PSC, such as hepatic encephalopathy, ascites, history of esophageal varices, portal hypertension, hepato-renal syndrome, portopulmonary syndrome, and hepato-pulmonary syndrome
• Evidence for viral hepatitis (history of Hepatitis C is eligible with undetectable HCV RNA); HIV/AIDS
• Metabolic or inherited liver disease (e.g., Wilson's, hemochromatosis, alpha-1-antitrypsin deficiency)
• Another disease involving bile ducts (e.g., primary biliary cholangitis, IgG4-related cholangitis, secondary sclerosing cholangitis)
• Evidence of cirrhosis on the last magnetic resonance cholangiopancreatography (within 6 months)
• Pregnancy or attempting to become pregnant or breastfeeding.
• History of liver transplantation, anticipated need for liver transplantation within 12- months from randomization, or a Model of End Stage Liver Disease (MELD) score of ≥15
• Active malignancy
• Active alcohol overuse (>4 drinks per day for men, and >2 drinks per day for women)
• Moderate-to-severe renal impairment with a calculated creatinine clearance of < 45 mL/min
• Neutropenia (an absolute neutrophil count < 0.5 x 109 cells/L)
• History of allergic reaction to vancomycin
• History of allergic reaction to amoxicillin or other beta-lactam antibiotics
• Any other conditions or abnormalities that, in the opinion of the investigator, may compromise the safety of the subject or interfere with the subject participating in or completing the study
• Total colectomy