The Study on the Association of Intestinal Flora and Early Post-stroke Depression in Patients With Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The Diversity of Intestinal Microbial Communities Calculated by OTU Analysis
研究概览
简要总结
The investigators aim to explore the relationship between gut microbiota composition and earlier poststroke depression via 16S rRNA sequencing.
详细描述
In this study, patients with first ever acute ischemic stroke were studied. According to the psychological assessment, patients were divided into two groups according to whether or not there was a PSD at the earlier stage of stroke. Clinical biological data and blood and feces samples were collected. Firstly, 16srDNA sequencing was used to study the difference in the composition and diversity of intestinal microbial communities in the two groups of patients. Then the two groups selected individual representative samples and conducted macro genome sequencing. At the same time, by analyzing the correlation between the intestinal flora and the clinical risk factors and neurotransmitters in early PSD patients, the key functional bacteria related to PSD were identified.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with the first ever acute ischemic stroke occurring within 2 weeks and were confirmed by CT or MRI,
- •has no history of depression or use of antidepressants or antipsychotics,
- •were competent to consent to take part in this research.
排除标准
- •significant acute or severe illness such as infection,heart failure and tumor,
- •previous diagnosis of depression or other mental disorder or who had recently accepted antidepressants or antipsychotics,
- •antibiotics in the last two weeks,
- •severe aphasia or dysarthria,irritable bowel syndrome,asthma,and pregnant or lactating women,
- •a previous history of neurological illness including AD and PD，
- •Inflammatory bowel disease，
结局指标
主要结局
The Diversity of Intestinal Microbial Communities Calculated by OTU Analysis
时间窗: 2 weeks
Community diversity measured in the Shannon index
The Poststroke Depression Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score
时间窗: 3 months
Mild depression（HAMD-17 Score\>7，≤17）, moderate depression（HAMD-17 Score\>17，≤24）, major depression（HAMD-17 Score\>24）
The Composition of Intestinal Microbial Communities Calculated by OTU Analysis
时间窗: 2 weeks
The composition were measured in number based on OTU data
Functional Independence Assessed by Modified Rankin Scale (mRS）score
时间窗: 3 months
MRS score range from 0 to 6. Favourable outcome (mRS score≤2), worse outcome (mRS score\>2), and death (mRS score = 6).
次要结局
- The Plasma Level of 5-Hydroxytryptamine( 5-HT) Neurotransmitter Using Enzyme-Linked Immunosorbent Assay ( ELISA) Methods(2 weeks)