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Primary Sclerosing CholangitisPhase 2VanC-ITNCT05876182

Vancomycin in Primary Sclerosing Cholangitis in Italy

A Phase 2 study testing Oral Vancomycin in people with Primary Sclerosing Cholangitis and Liver and Intrahepatic Bile Duct Disorder, run by University of Milano Bicocca at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 15 to 70 years
What is being tested?
Oral Vancomycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteItaly
Study dates
15 Jun 2023to Jun 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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);
  • Dose change within last 3 months prior to baseline of concomitant treatment with vitamin D or fibrates;
  • Treatment with any experimental drug within the previous three months;
  • Any known relevant infectious disease (e.g. active tuberculosis, AIDS defining disease);
  • History or active hearing problems;
  • Any active malignant disease;
  • Well found doubt about patient's cooperation, e.g. addiction to alcohol or drugs;
  • Imprisoned person, person admitted to nursing homes, persons under legal guardianship, and persons not able to express their consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marco Carbone, MD contact

0392334515

marco.carbone@unimib.it

Pietro Invernizzi, MD contact

039 233 2187

pietro.invernizzi@unimib.it

Italy1 site, 1 recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Monza E Brianza, 20900

    Marco Carbone, MD, 0392334515, marco.carbone@unimib.it

    Recruiting

Other trials in Italy

About this study

Official title: A Prospective, Randomized, Placebo-controlled Clinical Trial of Oral Vancomycin in Adults and Young Adults (15-17 Years Old) Affected by Primary Sclerosing Cholangitis With or Without Inflammatory Bowel Disease

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.

Read the detailed description

Primary sclerosing cholangitis (PSC) is chronic fibroinflammatory disease of the liver characterized by chronic inflammation and sclerosis of the intrahepatic and/or extrahepatic bile ducts, and a risk for progression to liver failure and development of colorectal and hepatobiliary cancer. Both children and adults are affected. Patients with PSC have a diminished life expectancy with a median survival of 17 years after diagnosis. Despite the high mortality associated with PSC and the efforts to optimize its management, there is no medical therapy proven to halt the progression of PSC or prevent its serious complications. There is a strong yet poorly understood relationship between PSC and inflammatory bowel disease (IBD); nearly 70%-80% of PSC patients have IBD, mainly ulcerative colitis (UC). Increasing evidence is pointing out the role of gut microbiota in the pathogenesis of PSC. The 'leaky gut' theory implies that either bacteria or their toxic metabolites translocate from the inflamed intestinal mucosa into the portal circulation and into the liver causing liver and biliary injury. The gut microbiota of PSC patients, compared to IBD patients and healthy controls, showed decreased microbial diversity, and over-represented intestinal pathobionts (i.e., organisms which, under normal circumstances, lives as a non-harming symbiont). Several antibiotics, including vancomycin and metronidazole, have been investigated in PSC. The use of oral vancomycin (OV), a glycopeptide antibiotic has been reported to be associated with improvement in clinical symptoms and laboratory abnormalities in patients with PSC; however, prospective studies in adult and young adult patients in Europe are lacking.

Our scientific community therefore seeks to examine the safety and efficacy of OV in patients with PSC in a randomized placebo-controlled clinical trial.

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 with or without IBD. The study will consist of 10-week screening period (including a run-in phase), 24 weeks of treatment, and follow-up visits at 4 and 12 weeks after completion of treatment to evaluate what happens after treatment stop. Subjects will be randomized to placebo or treatment and stratifying by baseline presence of fibrosis by fibroscan value at baseline (< or ≥14.4 kPa corresponding to F4 fibrosis), as this parameter could affect the likelihood of reaching the primary composite outcome measure.

The knowledge gained from our proposed clinical trial will help us determine if OV should be considered as a treatment option in patients with PSC. Furthermore, the use of state-of-the art technology applied in this study will shed light on the relationship between the gut microbiome, bile acids, immune-mediators, including cytokines, and PSC.

Being tested
Oral Vancomycin, Placebo
Keywords
liver, oral vancomycin, primary sclerosing cholangitis, Inflammatory bowel disease
Medical subject headings
Cholangitis, Sclerosing, Digestive System Diseases, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral VancomycinDrug

    Also called OV

    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.

  • PlaceboOther

    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.

Study groups in NCT05876182
Study groupRoleWhat they receive
Oral Vancomycin 750Experimental28 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).
Receives: Drug: Oral Vancomycin
Oral Vancomycin 1500Experimental28 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)
Receives: Drug: Oral Vancomycin
PlaceboPlacebo comparator28 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.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in alkaline phosphatase (ALP) levels

    ALP levels at 6 months

    Measured: From baseline to 6 months

Secondary outcomes (62)

  1. Safety and tolerability of OV in each treatment arm

    Adverse events

    Measured: From baseline to 6 months

  2. Clinical hematology

    White blood cells (10^3/uL)

    Measured: From baseline to 6 months

  3. Clinical hematology

    Hemoglobin (g/dl)

    Measured: From baseline to 6 months

  4. Clinical hematology

    Hematocrit (%)

    Measured: From baseline to 6 months

  5. Clinical hematology

    MCV (Mean Corpuscular Volume) (fL)

    Measured: From baseline to 6 months

  6. Clinical hematology

    Platelets (10^3/uL)

    Measured: From baseline to 6 months

  7. Clinical hematology

    Absolute neutrophils (10^3/uL)

    Measured: From baseline to 6 months

  8. Clinical hematology

    Absolute lymphocytes (10^3/uL)

    Measured: From baseline to 6 months

  9. Clinical hematology

    PT (Prothrombin Time, Ratio)

    Measured: From baseline to 6 months

  10. Clinical hematology

    INR

    Measured: From baseline to 6 months

  11. Clinical chemistry

    Total proteins (g/dl)

    Measured: From baseline to 6 months

  12. Clinical chemistry

    Albumin (g/dl)

    Measured: From baseline to 6 months

  13. Clinical chemistry

    Gamma (g/dl)

    Measured: From baseline to 6 months

  14. Clinical chemistry

    Sodium (mmol/l)

    Measured: From baseline to 6 months

  15. Clinical chemistry

    Creatinine (mg/dl)

    Measured: From baseline to 6 months

  16. Clinical chemistry

    Potassium (mmol/l)

    Measured: From baseline to 6 months

  17. Clinical chemistry

    Urea (mg/dl)

    Measured: From baseline to 6 months

  18. Clinical chemistry

    Glucose (mg/dl)

    Measured: From baseline to 6 months

  19. Clinical chemistry

    Total bilirubin (mg/dl)

    Measured: From baseline to 6 months

  20. Clinical chemistry

    Direct bilirubin (mg/dl)

    Measured: From baseline to 6 months

  21. Clinical chemistry

    GGT (U/l)

    Measured: From baseline to 6 months

  22. Clinical chemistry

    AST (U/l)

    Measured: From baseline to 6 months

  23. Clinical chemistry

    ALT (U/l)

    Measured: From baseline to 6 months

  24. Clinical chemistry

    Triglycerides (mg/dl)

    Measured: From baseline to 6 months

  25. Clinical chemistry

    Cholesterol (Total) (mg/dl)

    Measured: From baseline to 6 months

  26. Clinical chemistry

    High Density Lipoprotein (HDL Cholesterol) (mg/dl)

    Measured: From baseline to 6 months

  27. Clinical chemistry

    PCR (C Reactive Protein) (mg/dl)

    Measured: From baseline to 6 months

  28. Clinical chemistry

    IgG (mg/dl)

    Measured: From baseline to 6 months

  29. Clinical chemistry

    IgA (mg/dl)

    Measured: From baseline to 6 months

  30. Clinical chemistry

    IgM (mg/dl)

    Measured: From baseline to 6 months

  31. Clinical chemistry

    Ferritin (ng/ml)

    Measured: From baseline to 6 months

  32. Single 12-lead electrocardiograms

    Sinus rhythm

    Measured: From baseline to 6 months

  33. Single 12-lead electrocardiograms

    QTc (msec)

    Measured: From baseline to 6 months

  34. Urine analysis

    pH

    Measured: From baseline to 6 months

  35. Urine analysis

    Specific gravity

    Measured: From baseline to 6 months

  36. Urine analysis

    Hemoglobin

    Measured: From baseline to 6 months

  37. Urine analysis

    ACR (mg/g)

    Measured: From baseline to 6 months

  38. Urine analysis

    PCR (mg/g)

    Measured: From baseline to 6 months

  39. Vital sign measurements

    Body weight (kg)

    Measured: From baseline to 6 months

  40. Vital sign measurements

    Systolic blood pressure (mmHg)

    Measured: From baseline to 6 months

  41. Vital sign measurements

    Diastolic blood pressure (mmHg)

    Measured: From baseline to 6 months

  42. Vital sign measurements

    Heart Rate (bpm)

    Measured: From baseline to 6 months

  43. Vital sign measurements

    Temperature (°C)

    Measured: From baseline to 6 months

  44. Changes in the PSC score

    Revised Mayo Risk Score (Calculation formula = 0.03 (age [y]) + 0.54 loge (bilirubin [mg/dL]) + 0.54 loge (aspartate aminotransferase [U/L]) + 1.24 (variceal bleeding [0/1]) - 0.84 (albumin [g/dL]) (Higher scores indicate greater disease severity)

    Measured: From baseline to 6 months

  45. Changes in the IBD score

    Clinical Mayo Score (Partial Mayo Score) -(0-1=Remission; 2-4 = Mild activity; 5-7 = Moderate activity; 7-9 = Severe activity)

    Measured: From baseline to 6 months

  46. Liver stiffness measurements

    Stiffness (kPa/s)

    Measured: From baseline to 6 months

  47. Liver stiffness measurements

    Stiffness IQR/median (%)

    Measured: From baseline to 6 months

  48. Liver stiffness measurements

    CAP (dB/m)

    Measured: From baseline to 6 months

  49. Liver stiffness measurements

    CAP IQR/median (%)

    Measured: From baseline to 6 months

  50. MRCP (Magnetic Resonance Cholangiopancreatography)

    Disease localisation

    Measured: From baseline to 6 months

  51. MRCP (Magnetic Resonance Cholangiopancreatography)

    Presence of dominant stenosis

    Measured: From baseline to 6 months

  52. MRCP (Magnetic Resonance Cholangiopancreatography)

    Radiological signs of cirrhosis

    Measured: From baseline to 6 months

  53. Cytokines changes

    TGF-β levels

    Measured: From baseline to 6 months

  54. Cytokines changes

    IL-4 levels

    Measured: From baseline to 6 months

  55. Cytokines changes

    IL-13 levels

    Measured: From baseline to 6 months

  56. Cytokines changes

    IL-10 levels

    Measured: From baseline to 6 months

  57. Changes in the peripheral blood mononuclear cells

    Th1 and Th17 subsets isolation and analyses

    Measured: From baseline to 6 months

  58. Patients quality of life

    Visual analogue scale (VAS) score for itch

    Measured: From baseline to 6 months

  59. Patients quality of life

    Chronic Liver Disease Questionnaire (CLDQ)

    Measured: From baseline to 6 months

  60. Patients quality of life

    EQ-5D-5L questionnaire

    Measured: From baseline to 6 months

  61. Patients quality of life

    PSC patient reported outcome (PSC-PRO) questionnaire

    Measured: From baseline to 6 months

  62. Patients quality of life

    Inflammatory Bowel Disease Questionnaire (IBDQ)

    Measured: From baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2023
  2. Study start15 Jun 2023
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group A: vancomycin 750 mg daily Group B: vancomycin1500mg daily Group C: placebo
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05876182
Sponsor's protocol ID
VanC-IT
Acronym
VanC-IT
Status last verified
Jul 2025
First submitted
10 Mar 2023
Last updated
25 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cristoferi L, D'Amato D, Maino C, Bernasconi D, Dinelli ME, Malandrin SMI, Facciotti F, Vigano C, Pirola L, 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.

    PubMed 41513411

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oral Vancomycin in people with Primary Sclerosing Cholangitis and Liver and Intrahepatic Bile Duct Disorder, run by University of Milano Bicocca at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marco Carbone, MD (0392334515, marco.carbone@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in alkaline phosphatase (ALP) levels (time frame: From baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05876182, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.

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Vancomycin in Primary Sclerosing Cholangitis in Italy | AzTrials