Actively Recruiting
Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for PSC
Led by University of Minnesota · Updated on 2025-05-06
28
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 2 times the upper limit of normal
- No biliary obstruction or malignancy seen by ultrasound or equivalent imaging within 6 months before study entry
- Ability to maintain current medication regimen during the treatment period (including UDCA, azathioprine, corticosteroids, methotrexate, 5-ASA, biologic therapy, or probiotics)
- Completed a 3-month washout from obeticholic acid or other experimental PSC therapies
- Willingness to comply with all study procedures and available for follow-up by phone, in-person, email, or video
- Provided informed consent
You will not qualify if you...
- Antibiotic therapy other than vancomycin within 3 months or planned antibiotic use during MTT treatment
- Complications of advanced PSC such as hepatic encephalopathy, ascites, esophageal varices, portal hypertension, hepato-renal syndrome, portopulmonary syndrome, or hepato-pulmonary syndrome
- Evidence of viral hepatitis (except history of Hepatitis C with undetectable RNA) or HIV/AIDS
- Metabolic or inherited liver diseases like Wilson's disease, hemochromatosis, or alpha-1-antitrypsin deficiency
- Other bile duct diseases such as primary biliary cholangitis, IgG4-related cholangitis, or secondary sclerosing cholangitis
- Evidence of cirrhosis on recent magnetic resonance imaging within 6 months
- Pregnancy, attempting to become pregnant, or breastfeeding
- History of liver transplant, expected need for transplant within 12 months, or MELD score of 15 or higher
- Active cancer
- Excessive alcohol use (more than 4 drinks per day for men, more than 2 for women)
- Moderate to severe kidney impairment with creatinine clearance under 45 mL/min
- Neutropenia with absolute neutrophil count under 0.5 x 10^9 cells/L
- History of allergic reaction to vancomycin
- History of allergic reaction to amoxicillin or other beta-lactam antibiotics
- Any other condition that may affect safety or study participation as judged by the investigator
- Total colectomy
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
Research Team
A
Amanda Kabage
CONTACT
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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