Actively Recruiting
Vancomycin in Primary Sclerosing Cholangitis in Italy
Led by University of Milano Bicocca · Updated on 2025-07-25
84
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
U
University of Milano Bicocca
Lead Sponsor
G
Genetic s.p.a.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Primary sclerosing cholangitis (PSC) is chronic fibroinflammatory disease of the liver. There is still no medical therapy proven to halt the progression of PSC or prevent its serious complications. This is a Phase 2 randomized, double bind, placebo-controlled, monocentric study evaluating the safety and efficacy of two doses of oral vancomycin (i.e. 750 mg and 1500 mg/day) in subject between 15 - 70 years old with PSC.
CONDITIONS
Official Title
Vancomycin in Primary Sclerosing Cholangitis in Italy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to give informed consent before any study procedures
- Male and non-pregnant, non-lactating female subjects aged 15 to 70 years
- Diagnosed with large-duct PSC based on cholangiogram according to latest guidelines
- Baseline alkaline phosphatase (ALP) at least 1.5 times the upper limit of normal at screening
- No biliary obstruction or malignancy within 6 to 12 months before study entry
- Stable dose of ursodeoxycholic acid or 5-aminosalicylic acid if used
- At least 3 months since last antibiotic or probiotic treatment before study entry
- At least 3 months washout from obeticholic acid or other experimental PSC therapies before study entry
- PSC with or without IBD; IBD must be documented with minimum 6 months duration and in clinical remission or mild activity
- Female participants of childbearing potential must test negative for pregnancy at screening, baseline, and follow-ups and agree to use contraception if sexually active
- Male participants with female partners of childbearing potential must use condoms during treatment and relevant exposure period
You will not qualify if you...
- Antibiotic or probiotic use within 3 months before the study
- Expected need for antibiotics in the weeks before enrollment
- Allergy to vancomycin or teicoplanin
- Biliary intervention within 3 months before enrollment or planned
- Alcohol abuse exceeding defined limits
- Pregnancy or lactation
- Advanced kidney disease (GFR less than 70)
- Active hepatitis B or C infection
- Other chronic or cholestatic liver diseases or liver cancer
- History of cholangiocarcinoma (CCA)
- Advanced liver disease with complications or bilirubin over 4 mg/dL
- Listed for liver transplantation
- Moderate to severe uncontrolled IBD
- Recent immunosuppressive or corticosteroid treatment for IBD within 4 weeks
- Recent rifampicin treatment within 3 months
- Recent changes in vitamin D or fibrate doses within 3 months
- Experimental drug treatment within 3 months
- Active relevant infectious diseases
- History or presence of hearing problems
- Any active cancer
- Doubt about cooperation such as addiction
- Imprisonment, nursing home residency, legal guardianship, or inability to consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS San Gerardo dei Tintori
Monza, Monza E Brianza, Italy, 20900
Actively Recruiting
Research Team
M
Marco Carbone, MD
CONTACT
P
Pietro Invernizzi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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