NCT00870012已完成不适用
Treatment of Nonalcoholic Fatty Liver Disease With Probiotics and Prebiotics
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24.
研究概览
简要总结
The investigators' aim is to determine whether probiotic and prebiotic treatment plus lifestyle advice is more effective in reducing hepatic fat content than lifestyle advice alone in patients with Nonalcoholic Fatty Liver Disease (NAFLD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years
- •Fatty liver identified by imaging studies including ultrasound, computer tomography or magnetic resonance imaging
- •Elevated alanine aminotransferase (ALT) according to Prati's criteria (>30 IU/l in men and >19 IU/l in women)18
- •Written informed consent obtained
排除标准
- •Positive hepatitis B surface antigen, anti-hepatitis C virus antibody, or anti-nuclear antibody titer above 1/160
- •Alcohol consumption above 30 g per week in men or 20 g per week in women
- •ALT above 10 times the upper limit of normal
- •Liver decompensation, as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 109/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices
- •Use of systemic corticosteroids and methotrexate in the last 6 months
- •Evidence of hepatocellular carcinoma
- •Terminal illness or cancer, unless in complete remission for more than 5 years
研究组 & 干预措施
Lepicol probiotic & prebiotic formula+simple lifestyle advice
Active Comparator
干预措施: Lepicol probiotic & prebiotic formula (Drug)
Lepicol probiotic & prebiotic formula+simple lifestyle advice
Active Comparator
干预措施: Simple lifestyle advice (Other)
Simple lifestyle advice alone
Placebo Comparator
干预措施: Simple lifestyle advice (Other)
结局指标
主要结局
The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24.
时间窗: 24 weeks
次要结局
- The proportion of patients with normal ALT at week 24 will be determined. Normal ALT is defined according to Prati's cutoffs (≤30 IU/l in men and ≤19 IU/l in women).(24 weeks)
- The proportion of patients with impaired fasting glucose, diabetes, insulin resistance (estimated by the homeostasis model), hypertension, dyslipidemia and metabolic syndrome will be determined both at baseline and during each visit.(24 weeks)
- The changes in visceral fat will be determined by magnetic resonance imaging at the same session both at baseline and month 12.(12 months)
- The changes in liver fibrosis will be determined by transient elastography by Fibroscan both at baseline and month 12.(12 months)
- The percentage of total sequences of individual microbes will be calculated. In particular, the proportion of Firmicutes and Bacteroidetes will be compared between the two treatment arms.(12 months)
研究者
Henry LY Chan
Professor
Chinese University of Hong Kong
研究点 (1)
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