EUCTR2010-021515-17-GB进行中（未招募）不适用
RiFL: Rifaxamin in Fatty Liver Disease.Does Modulation of Gut Microbiota Reduce Hepatic Inflammation in Non-Alcoholic Steatohepatitis (NASH)? - Rifaximin in Fatty Liver v2.0
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject has provided written informed consent prior to screening
- •Men and women aged 18-70 years
- •Biopsy-proven NASH with no or mild to moderate fibrosis in the preceding year
- •Persistently abnormal ALT on 2 occasions
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •NAFLD with cirrhosis (fibrosis score 4)
- •Other causes of chronic liver disease
- •oViral hepatitis (HBV, HCV negative)
- •oAlcohol intake >14units/week (women) or >21units/week (men)
- •oHaemachromatosis (abnormal transferrin saturation, haemochromatosis genotyping)
- •Evidence of hepatic decompensation
- •oHepatic encephalopathy
- •oAbnormal total bilirubin (except patients with Gilbert’s syndrome), albumin, prolonged prothrombin time, low platelets)
- •oOesophageal or gastric varices
- •Moderate or severe renal dysfunction (CKD3+, estimated GFR <60ml/min/1.73m2)
- •Hepatocellular carcinoma
- •Primary metabolic causes of hepatic steatosis (e.g. familial hypertriglyceridaemia, abetalipoproteinaemia)
- •Other malignancy
- •Pregnant or lactating women or women of childbearing potential unwilling/unable to use adequate contraceptive methods
- •Systemic inflammatory conditions
- •oConnective tissue disorders
- •oInflammatory bowel disease
- •Myocardial infarction within 6 months
- •Stroke within 6 months
- •Bariatric surgery/ blind loop/ short bowel
- •Treatment known/suspected to change gut flora (e.g. systemic antibiotics, colestyramine, lactulose, polyethylene glycol) within 3 months
- •Treatment with drugs known to cause hepatic steatosis (e.g. corticosteroids, HAART, amiodarone, high dose oestrogens, tamoxifen) within 3 months
- •Initiation or major dose change of metformin, thiazolinediones, biguanides, statins, fibrates, anti-obesity medications or insulin within 3 months of enrolment
- •Patients with allergy to Rifaximin or Rifamycin
- •Patients with a cardiac pacemaker, history of penetrating eye injury, metal foreign body or any other contra-indication to MRI scanning, as specified in the local MRI safety checklist
- •Any other clinical, social or psychological issues which, in the opinion of the investigators may preclude satisfactory completion of the study protocol
研究者
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