Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for Primary Sclerosing Cholangitis
University of Minnesota
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.
Eligibility
- Age range
- 18–76 years
- Sex
- All
- 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 tele…
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.
Location
- University of MinnesotaMinneapolis, Minnesota