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Pilot Study of Oral Antibiotics for Primary Sclerosing Cholangitis (PSC)

This study is a pilot clinical trial for people with Primary Sclerosing Cholangitis (PSC), a chronic liver disease. It's testing the initial safety and feasibility of a treatment called microbiota transplant therapy (MTT). Before MTT, participants will receive oral vancomycin for 28 days and oral amoxicillin for 7 days. The study aims to see if this treatment is safe and practical for PSC patients. You may be able to join if you are between 18 and 76 years old, have a certain bilirubin level, and do not have bile duct blockage or cancer. The study plans to enroll 28 participants, but its current status is unclear.

Study design
This is an interventional pilot study, meaning participants will receive a specific treatment. It aims to enroll 28 participants.
What's involved
Participants will take oral vancomycin for 28 days and oral amoxicillin for 7 days. The study will evaluate safety and feasibility over 221 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and feasibility for 221 days after the treatment begins.

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NCT06197308

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

Recruiting
EARLY_PHASE1Ages 18–76InterventionalTreatment
University of Minnesota
~28 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:oral vancomycin and oral amoxicillin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate safety of MTT in patients with PSC
Measured over 221 days
+1 more outcome measured

Conditions

Primary Sclerosing Cholangitis

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Primary Sclerosing Cholangitis

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Elizabeth Aby · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Amanda Kabage
[email protected]
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • To evaluate safety of MTT in patients with PSC221 days

    Determine the frequency of serious adverse events and other adverse events

  • To evaluate feasibility of MTT in patients with PSC221 days

    Determine proportion of subjects taking 100% of the MTT per protocol.