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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: PSC Partners Seeking a Cure Foundation
• Treatments: Metronidazole; Vancomycin

Criteria

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 study.

• 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 Subjects becoming pregnant during the study will be withdrawn.