Research on the Association of Gut Microbes and Their Metabolites With Post-stroke Depression
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score
研究概览
简要总结
In this study, the clinical data of patients with AIS were collected, 16s RNA was used to detect the composition and diversity of intestinal flora, and flow cytometry and mass spectrometry were used to detect intestinal flora-related metabolites in plasma，to explore the influence of gut microbiota and its metabolites on stroke prognosis.
详细描述
In recent years, more and more studies have been conducted on the gut-brain axis, and gut microbes can affect the brain by regulating immune responses, metabolites, and neurotransmitters. The composition of gut microbiota may affect stroke prognosis, including focal neurological deficits, cognitive impairment, anxiety and depression, and fatigue. In this study, 16s RNA was used to detect the composition and diversity of intestinal flora, and flow cytometry and mass spectrometry were used to detect intestinal flora-related metabolites in plasma. The clinical data of patients were collected, including age, gender, and medical history, NIHSS, mRS, MMSE, Patient Health Questionnaire-9（PHQ9）, Social Support Rating Scale（SSRS）, laboratory and radiology results. The neurological recovery of the patients was assessed after 3 and 6 months, and the presence or absence of post-stroke depression（PSD） and post-stroke fatigue（PSF） was assessed by the Hamilton Depression Scale, the Fatigue Severity Scale（FSS） and the Multidimensional Fatigue Scale（MFS）. To evaluate the relationship between gut microbiota and its metabolites and stroke prognosis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who suffered from acute ischemic stroke
- •Within 7 days of the onset
- •Signing the informed consent, willing and able to attend all study visits
排除标准
- •Severe aphasia，dysarthria, hearing loss，cognitive and consciousness impairment and unable to cooperate
- •Previous diagnosis of depression or other mental disorder or who had recently accepted antidepressants or antipsychotics
- •Gastrointestinal disease, and pregnant or lactating women
- •Serious systemic diseases including malignant tumors
- •Any antibiotics, probiotics or prebiotic treatment within 1 months
结局指标
主要结局
The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score
时间窗: 6 months
Mild depression（HAMD-17 Score≥7，\<17）, moderate depression（HAMD-17 Score≥17，\<24）, major depression（HAMD-17 Score≥24）
The PSF Assessed by Fatigue Severity Scale（FSS）
时间窗: 6 months
Fatigue（FSS Score ≥36）
Functional Independence Assessed by Modified Rankin Scale (mRS）score
时间窗: 6 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
- Gut microbial composition and diversity(First stool after admission)
- Serum metabolites of gut microbiota(7 days within stroke onset)
- Serum inflammatory cytokines(7 days within stroke onset)