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
Summary
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 TreatmentChange 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information
Starting date: February 2010
Last updated: July 12, 2013
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