Safety and Efficacy of Probiotics in Primary Biliary Cholangitis (PBC) Patients With Poor Ursodeoxycholic Acid (UDCA) Response
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Biochemical response
研究概览
简要总结
The safety and efficacy of probiotics in primary biliary cholangitis (PBC) patients with poor ursodeoxycholic acid (UDCA) response.
详细描述
PBC patients with poor ursodeoxycholic acid (UDCA) response are selected and randomly assigned into probiotic group and control group. Patients in probiotic group receive probiotic(Micro V Probiotics) combined UDCA for 6 months and then continue to take UDCA alone. Patients in control group continue to take UDCA alone. Biochemical indicators, immunological indicators, liver stiffness, and ultrasound of the two groups of patients were collected. GLOBE and UK-PBC scoring system are used to assesse prognosis.The feces and serum of all patients are collected to observe the differences in fecal microbial polymorphisms in the two groups of patients. Metabolomics are used to study the differences in the bile acids and short chain fatty acid metabolites of the serum and feces of the two groups of PBC patients.
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
- Single (Investigator)
盲法说明
single(Investigator)
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
- •PBC patients (diagnosed with PBC according to 2009 AASLD PBC PRACTICE GUIDANCE), take UDCA more than 12 months and have poor response;
- •Age 18-70 years.
排除标准
- •Any other liver disesases (viral hepatitis, HIV positive, alcohol abuse, hemochromatosis, hepatolenticular degeneration, α1-antitrypsin deficiency and so on);
- •Important organ dysfunction such as heart, lung and kidney which affect the life expectancy;
- •Have congenital galactosemia, glucose malabsorption syndrome or lactase deficiency.
- •Patients allergic to research drugs or excipients;
- •Pregnant or lactating women;
- •Not signed informed consent;
- •Have antibiotics one month before enrollment;
- •Microecological preparations (probiotics, prebiotics, synbiotics, etc.) were used before the enrollment;
- •Malignant tumors, nerves and mental disorders;
- •Those who participated in other drug clinical trials in the past 3 months.
研究组 & 干预措施
Placebo group
Placebo (three times per day, one pack each time) and UDCA (13-15mg/kg/day), orally, 6 months
干预措施: Placebo (Dietary Supplement)
Probiotics group
Probiotics (three times per day, one pack each time) and UDCA(13-15mg/kg/day), orally, 6 months
干预措施: Probiotic (Drug)
结局指标
主要结局
Biochemical response
时间窗: 6 month
Percentage of patients with biochemical response (serum ALP(U/L) or GGT(U/L) decreased by 20% from baseline)
次要结局
未报告次要终点
研究者
Lin Bingliang
professor
Sun Yat-sen University