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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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.
University of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGTo evaluate safety of MTT in patients with PSC
Determine the frequency of serious adverse events and other adverse events
Time frame: 221 days
To evaluate feasibility of MTT in patients with PSC
Determine proportion of subjects taking 100% of the MTT per protocol.
Time frame: 221 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.