Study on Prevalence, Risk Factors and Intestinal Microecology of Clostridium Difficile Infection in Chinese Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 6
- 主要终点
- Prevalence rate of IBD with CDI in Chinese adults
研究概览
简要总结
In recent years, the incidence of Inflammatory Bowel Disease (IBD) has been increasing in China, which poses great challenges and burdens to the medical community due to its unknown etiology, recurrence and incurability. Co-infection is one of the important causes in IBD development. IBD accompanied with Clostridium Difficile Infection (CDI) can significantly decrease the treatment efficiency, leading to increased surgical rate, increased mortality, prolonged hospital stay, and increased hospital costs. Recently, several Chinese clinical guidelines about IBD or CDI have been published, but these guidelines are mainly based on the foreign studies. Compared with the developed countries, the lack of multi-center, large-scale and multi-test clinical trials and cohort studies caused limited understanding for IBD-CDI in China. Therefore, it is of great importance to carry out the multi-center clinical trials and analysis on IBD-CDI to improve the diagnostic and therapeutic efficiency in IBD-CDI patients
Objective:
- To evaluate the prevalence rate of IBD-CDI in Chinese adults in China based on the multi-center clinical trials..
- To analyze the related risk factors of IBD-CDI in China based on the multi-center clinical trials.
- To analyze the intestinal flora of IBD-CDI patients via high-throughput sequencing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.Inpatients with diagnostic criteria for ulcerative colitis and Crohn's disease in accordance with the consensus opinion on the diagnosis and treatment of inflammatory bowel disease in China in 2012
- •2.Willing to participate in the study;
- •Have the ability to understand and sign informed consent.
排除标准
- •1.Patients with infectious enteritis, intestinal tuberculosis, lymphoma, Behcet's disease or other intestinal diseases except inflammatory bowel disease;
- •2.Pregnant or lactating women;
- •3.Severe circulatory system, respiratory system, blood system, immune system, urinary system and other combined diseases or serious psychosomatic diseases.
结局指标
主要结局
Prevalence rate of IBD with CDI in Chinese adults
时间窗: 3 years
To analyze the prevalence rate of IBD with CDI in Chinese adults based on the multicenter clinical trials.
次要结局
- Gut microbiota in patients with IBD-CDI，IBD and healthy volunteers by 16S rDNA sequencing(3 years)
- Risk factors of IBD with CDI in China(3 years)