Predictive Value of Human Microbiome and Serological Markers for Clinical Outcome of Cerebral Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Neurological function score (mRS score)
研究概览
简要总结
Objective: To explore the predictive value of characteristic disorder of intestinal flora for clinical prognosis in patients with intracerebral hemorrhage. Secondary objectives: 1) To investigate the correlation of gut microbiota and its serological indicators with imaging features and clinical neurological deficits in ICH; 2) Dynamically observe the changes of human microbiome and its serological indicators after ICH, and explore the biomarkers based on human microbiome related to disease changes.
详细描述
Spontaneous intracerebral hemorrhage has brought a heavy burden to society and families. Finding biomarkers closely related to the condition of intracerebral hemorrhage is an important research direction for the prevention and treatment of intracerebral hemorrhage. However, there are few studies on the correlation between cerebral hemorrhage and microbiota. Our previous small sample study found that there were intestinal flora and SCFAs metabolism disorders in patients with hypertensive cerebral hemorrhage, and the latter was significantly related to poor prognosis. These results suggest that gut microbiota and its metabolites may become prognostic predictors and therapeutic targets for patients with intracerebral hemorrhage. However, more research evidence is still needed to confirm. Therefore, this study hypothesized that oral or intestinal flora in patients with acute cerebral hemorrhage has a certain degree of disorder and dynamic changes, accompanied by changes in serum markers, and there is a potential relationship between the changes of some microbiota-related markers and the severity and outcome of cerebral hemorrhage. Therefore, this topic proposed collection in patients with acute cerebral hemorrhage oral swabs, blood and feces or anal swab specimens, evaluate the neurological function score, imaging features and clinical outcomes, and to establish a follow-up queue, the dynamic change of cerebral hemorrhage patients after intestinal bacterial flora and condition and poor prognosis, the correlation of biomarkers new prediction and prevention of brain hemorrhage, To improve the effectiveness of prevention and treatment of cerebral hemorrhage.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •It meets the diagnostic criteria for acute ischemic stroke
- •Age ≥ 18 years
- •The onset time is less than or equal to 2 weeks
- •Diagnosis of cancer before stroke onset or during hospitalization and active cancer (failure to meet clinical criteria for cure, or discovery of recurrence or metastasis)
- •Sign an informed consent form, provide relevant medical history information and provide biological specimens
排除标准
- •Previous history of disabling stroke (pre-onset mRS ≥2)
- •Primary central nervous system tumor or hematologic system tumor
- •The cancer meets the criteria for clinical cure and has not recurred or metastasized for more than 5 years
- •Antibiotics, prebiotics/probiotics taken within 1 month
- •Patients who cannot have stool specimens within 4 days of admission
结局指标
主要结局
Neurological function score (mRS score)
时间窗: 3 months after onset
Neurological function score (mRS score)
mortality
时间窗: within 12 months after onset
mortality
次要结局
- New cerebrovascular events(within 12 months after onset)
- NIHSS(The first day and the seventh day after admission, 3 months, 6 months and 12 months after onset)
- Montreal Cognitive Assessment(The first day and the seventh day after admission、3 months and 6 months after onset)
- Barthel Index(3 months, 6 months and 12 months after onset)
- Mini-mental State Examination(The first day and the seventh day after admission, 3 months and 6 months after onset)