Predictive Value of Gut Microbiota and Serum Markers for Cognitive Impairment and Poor Prognosis After Ischemic Stroke: A Multiple Center Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Mini-Mental State Examination
研究概览
简要总结
Post-stroke cognitive impairment(PSCI) is one of the most important factors causing disabilities after stroke. Recent study found that gut microbiota plays a key role in neurological diseases. Two recent small sample studies reported gut dysbiosis in PSCI patients. In order to further verify the relationship between PSCI and gut microbiota and the predictive value of gut microbiota and serum markers for cognitive impairment and poor prognosis after ischemic stroke. The study intended to collect stool specimens of patients with acute ischemic stroke and assess their cognitive psychological state, and to establish a prospective multi-center follow-up cohort to explore the correlation between the dynamic changes of intestinal flora in patients with stroke and PSCI and poor prognosis of stroke.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for acute ischemic stroke;
- •Aged between 18-75;
- •Onset within 7 days;
- •Sign informed consent and agree to provide relevant medical history data and biological specimens.
排除标准
- •Patients diagnosed with TIA
- •Severe disturbance of consciousness (NIHSS consciousness score > 1)
- •Previous severe mental disorders and dementia (AD8 score ≥ 2)
- •History of cerebral hemorrhage or any stroke within 12 months;
- •Serious systemic diseases including malignant tumors
- •Patients with aphasia and unable to cooperate to complete the Montreal Cognitive Assessment (MoCA)
- •ALT or AST greater than 2 times the upper limit of normal value or severe liver disease;
- •GFR less than 30mL/min/1.72m2 or severe kidney disease
- •Alcohol abused, drug use and chemical poisoning history (such as pesticide poisoning)
- •Patients with previous history of gastrointestinal tract or confirmed during hospitalization
- •Patients who could not collect stool samples within 4 days after admission.
结局指标
主要结局
Mini-Mental State Examination
时间窗: 6 months after discharge
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
Montreal Cognitive Assessment
时间窗: 6 months after discharge
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
Gut microbiota
时间窗: 3 months after discharge
Results of fecal bacteria by 16s RNA sequencing
次要结局
- National Institute of Health stroke scale(NIHSS)(6 months after discharge)
- Short chain fatty acids(3 months after discharge)
- Modified Rankin Scale(mRS)(12 months after discharge)
- Trimethylamine-N-Oxide(3 months after discharge)
- Untargeted Metabolomics(3 months after discharge)