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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Mayo Clinic

Current Primary Outcome: Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment [ Time Frame: baseline, 12 weeks ]

Original Primary Outcome: The primary endpoint will be the change in alkaline phosphatase following 12 weeks of treatment with each antibiotic, compared to the baseline value. [ Time Frame: 12 weeks ]

Current Secondary Outcome:

  • Change From Baseline in Total Bilirubin Following 12 Weeks Treatment [ Time Frame: baseline, 12 weeks ]
  • Change From Baseline in Mayo PSC Risk Score Following 12 Weeks of Treatment [ Time Frame: baseline, 12 weeks ]
    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.
  • Change From Baseline in C-Reactive Protein Following 12 Weeks of Treatment [ Time Frame: baseline, 12 weeks ]


Original Secondary Outcome: Frequency of adverse events, comparison of change in alkaline phosphatase, AST, total bilirubin and Mayo risk score after 12 weeks of therapy, & change in pruritus, VAS score and fatigue severity as quantified by the questionnaires compared to baseline. [ Time Frame: 12 weeks ]

Information By: Mayo Clinic

Dates:
Date Received: March 10, 2010
Date Started: February 2010
Date Completion:
Last Updated: July 12, 2013
Last Verified: July 2013