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A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Sclerosing Cholangitis

Intervention: Vancomycin (Drug); Vancomycin (Drug); Metronidazole (Drug); Metronidazole (Drug); Vancomycin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Jayant A Talwalkar, MD, Principal Investigator, Affiliation: Mayo Clinic


The purpose of this study is to determine whether Vancomycin or Metronidazole is safe and beneficial in the treatment of Primary Sclerosing Cholangitis.

Clinical Details

Official title: A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment

Secondary outcome:

Change From Baseline in Total Bilirubin Following 12 Weeks Treatment

Change From Baseline in Mayo PSC Risk Score Following 12 Weeks of Treatment

Change From Baseline in C-Reactive Protein Following 12 Weeks of Treatment

Detailed description: In this protocol, we propose the assessment of potential beneficial effects of the antibiotics vancomycin and metronidazole on liver biochemistries, liver related symptoms and Mayo risk score in patients with PSC. The patients will be randomized into four groups of ten patients: one group will receive low dose vancomycin, one group will receive high dose vancomycin, one group will receive low dose metronidazole and one group will receive high dose metronidazole. Each group will be treated for three months.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria:

- Diagnosis of PSC established by alkaline phosphatase >1. 5 times and/or two fold

elevation of liver transaminases (AST and/or ALT) for at least 6 months duration.

- Cholangiography demonstrating intrahepatic and/or extrahepatic biliary obstruction,

beading, or narrowing consistent with PSC.

- Both genders.

- Age ≥ 18 years old and < than 75 years old.

- Patient's informed consent for study participation.

Exclusion Criteria:

- Treatment with systematic antibiotics, azulfidine, ursodeoxycholic acid,

corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline, tacrolimus, silymarin or prednisone in the preceding three months.

- Active drug or alcohol use.

- Prior history of allergic reactions to the antibiotics which will be used in the


- Any condition that, in the opinion of the investigator, would interfere with the

patients' ability to complete the study safely or successfully.

- Evidence of decompensated liver disease such as recurrent variceal bleeding,

refractory ascites or spontaneous hepatic encephalopathy.

- Anticipated need for transplantation in one year (Mayo survival model <80% one-year

survival without transplant).

- Findings highly suggestive of liver disease of other etiology such as chronic

alcoholic liver disease, chronic hepatitis B or C infection, hemochromatosis, Wilson's disease, 1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis or secondary sclerosing cholangitis.

- Pregnancy or current lactation. Subjects becoming pregnant during the study will be


Locations and Contacts

Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information

Starting date: February 2010
Last updated: July 12, 2013

Page last updated: August 23, 2015

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