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

Mayo Clinic

Status and phase

Completed

Phase 1

Conditions

Primary Sclerosing Cholangitis

Treatments

Drug: Vancomycin

Drug: Metronidazole

Study type

Interventional

Funder types

Other

Identifiers

NCT01085760

08-008247

Details and patient eligibility

About

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

Full 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.

Enrollment

35 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

35 participants in 4 patient groups

Vancomycin 125 mg orally 4 times a day

Experimental group

Description:

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.

Treatment:

Drug: Vancomycin

Vancomycin 250 mg orally 4 times a day

Experimental group

Treatment:

Drug: Vancomycin

Metronidazole 250 mg orally 3 times a day

Experimental group

Treatment:

Drug: Metronidazole

Metronidazole 500 mg orally 3 times a day

Experimental group