A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment
研究概览
简要总结
The purpose of this study is to determine whether Vancomycin or Metronidazole is safe and beneficial in the treatment of Primary Sclerosing Cholangitis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Vancomycin (Drug)
Vancomycin 250 mg orally 4 times a day
干预措施: Vancomycin (Drug)
Metronidazole 250 mg orally 3 times a day
干预措施: Metronidazole (Drug)
Metronidazole 500 mg orally 3 times a day
干预措施: Metronidazole (Drug)
结局指标
主要结局
Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment
时间窗: baseline, 12 weeks
次要结局
- Change From Baseline in Total Bilirubin Following 12 Weeks Treatment(baseline, 12 weeks)
- Change From Baseline in Mayo PSC Risk Score Following 12 Weeks of Treatment(baseline, 12 weeks)
- Change From Baseline in C-Reactive Protein Following 12 Weeks of Treatment(baseline, 12 weeks)