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

NCT ID: NCT01085760

Last Updated: 2013-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-11-30

Brief Summary

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

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.

Conditions

Primary Sclerosing Cholangitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vancomycin 125 mg orally 4 times a day

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.

Group Type: EXPERIMENTAL

Vancomycin

Intervention Type: DRUG

Comparison of different doses of drug

Vancomycin

Intervention Type: DRUG

Comparison of different drug doses

Vancomycin 250 mg orally 4 times a day

Group Type: EXPERIMENTAL

Vancomycin

Intervention Type: DRUG

Comparison of different doses of drug

Metronidazole 250 mg orally 3 times a day

Group Type: EXPERIMENTAL

Metronidazole

Intervention Type: DRUG

Comparison of different doses of drug

Metronidazole 500 mg orally 3 times a day

Group Type: EXPERIMENTAL

Metronidazole

Intervention Type: DRUG

Comparison of different doses of drug

Interventions

Vancomycin

Comparison of different doses of drug

Intervention Type: DRUG

Vancomycin

Comparison of different doses of drug

Intervention Type: DRUG

Metronidazole

Comparison of different doses of drug

Intervention Type: DRUG

Metronidazole

Comparison of different doses of drug

Intervention Type: DRUG

Vancomycin

Comparison of different drug doses

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PSC Partners Seeking a Cure

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Jayant A. Talwalkar

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jayant A Talwalkar, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

Tabibian JH, Weeding E, Jorgensen RA, Petz JL, Keach JC, Talwalkar JA, Lindor KD. Randomised clinical trial: vancomycin or metronidazole in patients with primary sclerosing cholangitis - a pilot study. Aliment Pharmacol Ther. 2013 Mar;37(6):604-12. doi: 10.1111/apt.12232. Epub 2013 Feb 5.

Reference Type: DERIVED

PMID: 23384404 (View on PubMed)

Other Identifiers

08-008247

Identifier Type: -

Identifier Source: org_study_id