Primary Sclerosing Cholangitis
Conditions
Brief summary
This pilot clinical trial will evaluate the initial safety and feasibility of microbiota transplant therapy (MTT) inpatients with primary sclerosing cholangitis (PSC). This trial will inform development of future trials in treatment of PSC.
Interventions
DRUGoral vancomycin and oral amoxicillin
In this study, PSC patients will receive an antibiotic preconditioning regimen of oral vancomycin (500 mg liquid twice a day) for 28 days and oral amoxicillin (1000 mg twice a day) for 7 days (during the last 7 days of the oral vancomycin). Following vancomycin and amoxicillin, encapsulated, freeze-dried microbiota preparation (MTP-101C) will be administered - dosed at ≥ 5 x 10\^11 bacteria (five capsules) daily for 3 days followed by ≥ 2 x 10\^11 bacteria (two capsules) for 11 days - for a total of 14 days of MTP-101C; total of 37 capsules.
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Adult patients with PSC
Eligibility
Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate safety of MTT in patients with PSC | 221 days | Determine the frequency of serious adverse events and other adverse events |
| To evaluate feasibility of MTT in patients with PSC | 221 days | Determine proportion of subjects taking 100% of the MTT per protocol. |
Countries
United States
Contacts
CONTACTAmanda Kabage
PRINCIPAL_INVESTIGATORElizabeth Aby
University of Minnesota
Outcome results
None listed