Using oral microbiota therapy to treat primary sclerosing cholangitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot clinical trial aims to evaluate the safety and feasibility of microbiota transplant therapy (MTT) in patients diagnosed with primary sclerosing cholangitis (PSC). Participants will receive oral vancomycin and oral amoxicillin as part of the treatment regimen. The study will assess the initial responses to this therapy, which could inform the design of larger future trials targeting PSC. The trial will include a follow-up period to monitor patient outcomes and adherence to treatment protocols.

Why it matters

Who can join: the full rules

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 telephone, in-person, email, and/or video visits or correspondence.
* Informed consent

Exclusion Criteria:

* 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

Where it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Elizabeth Aby — University of Minnesota
• Study coordinator: Amanda Kabage
• Email: kabage@umn.edu

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.