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

Primary Sclerosing Cholangitis Clinical Trial

— PSC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085760
• Other study ID #: 08-008247
• Status: Completed
• Phase: Phase 1
• First received: March 10, 2010
• Last updated: July 12, 2013
• Start date: February 2010
• Est. completion date: November 2011

Study information

• Verified date: July 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis

Intervention

Drug:
• Vancomycin
Comparison of different doses of drug
• Vancomycin
Comparison of different doses of drug
• Metronidazole
Comparison of different doses of drug
• Metronidazole
Comparison of different doses of drug
• Vancomycin
Comparison of different drug doses

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	PSC Partners Seeking a Cure Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment		baseline, 12 weeks	No
Secondary	Change From Baseline in Total Bilirubin Following 12 Weeks Treatment		baseline, 12 weeks	No
Secondary	Change From Baseline in Mayo PSC Risk Score Following 12 Weeks of Treatment	The Mayo PSC risk score was calculated for each patient at baseline and at 12 weeks, where Risk = 0.03 (age [years]) + 0.54 Ln (total bilirubin [mg/dL]) + 0.54 Ln (AST [IU/L]) + 1.24 (variceal bleeding) - 0.84 (albumin [g/dL]). There is no range, minimum, or maximum value but greater values indicate worse disease.	baseline, 12 weeks	No
Secondary	Change From Baseline in C-Reactive Protein Following 12 Weeks of Treatment		baseline, 12 weeks	No