Actively Recruiting
Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for Primary Sclerosing Cholangitis
Led by University of Minnesota · Updated on 2026-05-20
28
Participants Needed
1
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the initial safety and feasibility of microbiota transplant therapy (MTT) in patients with primary sclerosing cholangitis (PSC), a liver disease. This early-phase pilot trial aims to gather information that will help design future studies for treating PSC. The study is sponsored by the University of Minnesota and focuses on exploring this new treatment approach. Participants will receive an antibiotic preconditioning regimen consisting of oral vancomycin (500 mg liquid twice daily) for 28 days and oral amoxicillin (1000 mg twice daily) for 7 days overlapping with the last week of vancomycin. Following this, a freeze-dried microbiota preparation (MTP-101C) is given orally as capsules, with five capsules daily for 3 days, then two capsules daily for 11 days, totaling 14 days of treatment and 37 capsules overall. During the trial, participants will be monitored for safety and how well they tolerate the therapy over 221 days. Researchers will assess outcomes such as adverse effects and feasibility of the treatment. Participants will have follow-up visits and communications via telephone, in-person, email, or video during the study period. The study includes baseline imaging and lab tests to ensure eligibility and monitor health status throughout the trial.
CONDITIONS
Brief Title
Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for PSC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18-76
- Serum total bilirubin at screening less than or equal to twice the upper limit of normal
- No biliary obstruction or malignancy confirmed by ultrasound or similar imaging within 6 months
- Stable medication regimen during treatment period including UDCA, azathioprine, corticosteroid, methotrexate, 5-ASA, biologic therapy, or probiotic
- At least 3 months washout from obeticholic acid or other experimental PSC therapies
- Willingness to comply with all study procedures and availability for follow-up by telephone, in-person, email, or video
- Provided informed consent
You will not qualify if you...
- Antibiotic therapy other than vancomycin within 3 months or expected antibiotic use during MTT treatment
- Advanced PSC complications such as hepatic encephalopathy, ascites, esophageal varices, portal hypertension, hepato-renal syndrome, portopulmonary syndrome, or hepato-pulmonary syndrome
- Viral hepatitis (except history of Hepatitis C with undetectable RNA) or HIV/AIDS
- Metabolic or inherited liver diseases like Wilson's, hemochromatosis, or alpha-1-antitrypsin deficiency
- Other bile duct diseases such as primary biliary cholangitis or IgG4-related cholangitis
- Cirrhosis evidence on recent magnetic resonance cholangiopancreatography
- Pregnancy, breastfeeding, or trying to become pregnant
- History or anticipated need for liver transplantation within 12 months or MELD score 15 or higher
- Active malignancy
- Excessive alcohol use (more than 4 drinks per day for men, 2 for women)
- Moderate-to-severe kidney impairment with creatinine clearance less than 45 mL/min
- Neutropenia with absolute neutrophil count less than 0.5 x 10^9 cells/L
- Allergies to vancomycin or amoxicillin/beta-lactam antibiotics
- Total colectomy
- Any other condition that may compromise safety or participation as judged by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 49 days
Participants receive an antibiotic preconditioning regimen of oral vancomycin for 28 days and oral amoxicillin for 7 days, followed by a 14-day course of encapsulated, freeze-dried microbiota preparation (MTP-101C).
Multiple visits during treatment period
Duration - Up to 221 days
Participants are monitored for safety and feasibility of the microbiota-based therapeutic for up to 221 days after treatment starts.
Periodic visits and contacts for up to 221 days
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
Research Team
A
Amanda Kabage
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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