The purpose of this study is to determine whether Vancomycin or Metronidazole is safe and beneficial in the treatment of Primary Sclerosing Cholangitis.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Comparison of different doses of drug
Comparison of different doses of drug
Comparison of different doses of drug
Mayo Clinic
Rochester, Minnesota, United States
Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment
Time frame: baseline, 12 weeks
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
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.
Time frame: baseline, 12 weeks
Change From Baseline in C-Reactive Protein Following 12 Weeks of Treatment
Time frame: baseline, 12 weeks
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Comparison of different doses of drug
Comparison of different drug doses