Vancomycin in Primary Sclerosing Cholangitis in Italy

NCT05876182 | Recruiting Phase 2

• 1 other identifier: VanC-IT
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Primary Sclerosing Cholangitis; Liver and Intrahepatic Bile Duct Disorder; IBD

Keywords

liver; oral vancomycin; primary sclerosing cholangitis; Inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in alkaline phosphatase (ALP) levels

  ALP levels at 6 months

  From baseline to 6 months

Secondary Outcomes (62)

• Safety and tolerability of OV in each treatment arm

  From baseline to 6 months

• Clinical hematology

  From baseline to 6 months

• Clinical hematology

  From baseline to 6 months

• Clinical hematology

  From baseline to 6 months

• Clinical hematology

  From baseline to 6 months

Study Arms (3)

Oral Vancomycin 750

EXPERIMENTAL

28 subjects with PSC will be randomized to this arm. They will take 2 tablet (1 of vancomycin 250 mg and 1 of placebo), three times a day administered orally (total dose 750 mg/daily).

Drug: Oral Vancomycin

Oral Vancomycin 1500

EXPERIMENTAL

28 subjects with PSC will be randomized to this arm.They will take 2 tablet of 250 mg of vancomycin three times a day administered orally (total dose 1500mg/daily)

Drug: Oral Vancomycin

Placebo

PLACEBO COMPARATOR

28 subjects with PSC will be randomized to this arm. They will take 2 tablet (placebo-to-match oral vancomycin) administered orally three times a day.

Other: Placebo

Interventions

Oral Vancomycin DRUG

The investigator will identify potential participants and confirm the diagnosis of PSC. Subjects will be screened within 10 weeks before randomization to determine the eligibility. Study participants will be consecutively randomized to oral vancomycin or placebo and investigational drug and placebo dispensed.

Also known as: OV

Oral Vancomycin 1500; Oral Vancomycin 750

Placebo OTHER

The investigator will identify potential participants and confirm the diagnosis of PSC. Subjects will be screened within 10 weeks before randomization to determine the eligibility. Study participants will be consecutively randomized to oral vancomycin or placebo and investigational drug and placebo dispensed.

Placebo

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give informed consent prior to any study specific procedure being performed;
• Male and non-pregnant, non-lactating female subjects, including women of child bearing potential (WOCBP), between 15-70 years of age at the time of informed consent;
• Diagnosis of large-duct PSC based on cholangiogram (at MRCP, ERCP, PTC) according to the most recent published guidelines (EASL);
• Baseline ALP ≥1.5 times upper limit normal at screening;
• Absence of biliary obstruction and/or malignancy within 6-12 months of entry into the study;
• If a patient is on ursodeoxycholic acid (UDCA) or 5-aminosalicylic acid he or she is expected to remain on the same daily dose during the study period;
• Patients who received antibiotics or probiotics may participate if they had a washout period of at least 3-month prior to study entry;
• If a patient has been on obeticholic acid or other experimental therapies (e.g. cilofexor and norUDCA) for PSC, they must complete a 3-month washout period before study entry;
• PSC with or without IBD. IBD diagnosis should be documented and with a minimum disease duration of 6 months, as determined by endoscopic and histopathology assessment. IBD should be in clinical remission or mildly active according to CDAI and partial Mayo score for CD and UC, respectively (i.e. patients with CDAI score \< 220 and pMayo score \<5). Patients without documented IBD need a colonoscopy with segmental biopsies within 12 months prior to baseline visit;
• Female subjects of childbearing potential must test negative for pregnancy at screening, baseline and follow-up visits and if engage in sexual intercourse must agree to use specific methods of contraception.
• Male subjects with female partners of childbearing potential must use condoms during treatment and until the end of relevant systemic exposure.

You may not qualify if:

• Receiving an antibiotic or probiotic within 3 months prior to the study;
• Expected to receive antibiotics within the weeks leading up to enrollment (such as patients with recurrent cholangitis, ongoing infectious illnesses, etc.);
• Allergy to vancomycin or teicoplanin;
• Biliary intervention within 3 months prior to study enrollment or planned;
• Alcohol abuse (defined as greater than 14 standard drinks units per week in men; greater than 7 standard drinks units per week);
• Pregnancy and lactation;
• Advanced renal disease (GFR\< 70);
• Active hepatitis B and/or C infection;
• Other chronic or cholestatic liver diseases such as PBC, autoimmune hepatitis, nonalcoholic steatohepatitis, alcoholic liver disease, Wilson's disease, hemochromatosis, α-1 antitrypsin deficiency, IgG4-related sclerosing cholangitis, and liver cancer;
• History of CCA;
• Advanced liver disease (history of variceal bleeding, ascites, hepatic encephalopathy, and/or bilirubine \>4 mg/dL);
• On active transplantation list;
• IBD with uncontrolled moderate to severe activity;
• Active treatment or within the previous four weeks (washout period) with any immunosuppressive medication for controlling IBD (i.e. azathioprine, 6-mercaptopurine, tacrolimus, methotrexate, infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, ozanimod). Treatment with corticosteroids (including budesonide, budesonide MMX and beclomethasone) in the previous four weeks
• Active treatment with rifampicin or within the previous three months (washout period);

Sponsors & Collaborators

• University of Milano Bicocca: lead
• Genetic s.p.a.: collaborator

Study Sites (1)

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza E Brianza, 20900, Italy

RECRUITING

Related Publications (1)

• Cristoferi L, D'Amato D, Maino C, Bernasconi D, Dinelli ME, Malandrin SMI, Facciotti F, Festa MM, Gerussi A, Rossi E, Malinverno F, Tettamanti P, Cazzaniga ME, Corso R, Ippolito D, Galimberti S, Invernizzi P, Carbone M. Prospective, randomised, placebo-controlled, phase 2 clinical trial assessing the efficacy and safety of oral vancomycin in patients with primary sclerosing cholangitis with/out inflammatory bowel disease in Italy: study protocol of VanC-IT trial. BMJ Open. 2026 Jan 9;16(1):e106630. doi: 10.1136/bmjopen-2025-106630.

  PMID: 41513411 DERIVED

MeSH Terms

Conditions

Cholangitis, Sclerosing; Digestive System Diseases; Inflammatory Bowel Diseases

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Gastroenteritis; Gastrointestinal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Marco Carbone, MD

CONTACT

0392334515; marco.carbone@unimib.it

Pietro Invernizzi, MD

CONTACT

039 233 2187; pietro.invernizzi@unimib.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: During the randomization phase, subjects and all personnel directly involved in the conduct of the study will be blinded to the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group A: vancomycin 750 mg daily Group B: vancomycin1500mg daily Group C: placebo

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: May 25, 2023
• Study Start: June 15, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)