A Clinical Study About Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- fecal microbial diversity
研究概览
简要总结
To compare intestinal flora diversity in different PBC patients with UDCA responses, and further study the differences of bile acid metabolism and short chain fatty acid metabolism in feces and serum of two groups of PBC patients.
详细描述
The PBC patients have been enrolled in the study for UDCA treatment more than 1 year, who is divided into the UDCA total response Group and the other poor response group according to Paris-I/II standard .The feces of two groups of patients were collected and the differences of microbial polymorphism of fecal microorganism in two groups were observed. The metabolic differences of bile acids and short chain fatty acids in serum and feces of two groups of PBC patients were studied by means of metabolic proteomics.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Confirmed diagnostic criteria about PBC, and orally UDCA treatment for more than a year; 2.30-70 years old; 3.Currently only UDCA therapy, not glucocorticoids and immunosuppressor treatment.
排除标准
- •Viral liver disease;
- •alcoholic liver disease;
- •fatty liver;
- •drug-associated liver damage;
- •infectious disease;
- •gastrointestinal diseases;
- •combined with other autoimmune diseases;
- •cardiac and pulmonary dysfunction;
- •renal dysfunction, malignant tumor,;
- •neurological and psychiatric abnormalities;
- •nearly 2 months to take antibiotics and probiotics;
- •nearly 3 months participate in other drug clinical trials .
结局指标
主要结局
fecal microbial diversity
时间窗: 6 months
Macrogenomic examination of fecal microbial DNA
次要结局
- bile acid metabolites(6 months)
- short chain fatty acid metabolites(6 months)
研究者
Lin Bingliang
professor
Sun Yat-sen University