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

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

March 31, 2027

Study Completion Date

September 1, 2027

Conditions
Primary Sclerosing Cholangitis
Interventions
DRUG

oral 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.

Trial Locations (1)

55414

RECRUITING

University of Minnesota, Minneapolis

All Listed Sponsors
lead

University of Minnesota

OTHER