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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSD | Depressed as assessed by the Hamilton Depression Scale 3 months after stroke | ||
| Non PSD | Nondepressed as assessed by the Hamilton Depression Scale 3 months after stroke |
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| Measure | Description | Time Frame |
|---|---|---|
| The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score | Mild depression（HAMD-17 Score≥7，<17）, moderate depression（HAMD-17 Score≥17，<24）, major depression（HAMD-17 Score≥24） | 3 months |
| The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score | Mild depression（HAMD-17 Score≥7，<17）, moderate depression（HAMD-17 Score≥17，<24）, major depression（HAMD-17 Score≥24） | 6 months |
| The PSF Assessed by Fatigue Severity Scale（FSS） | Fatigue（≥36） | 3 months |
| The PSF Assessed by Fatigue Severity Scale（FSS） | Fatigue（FSS Score ≥36） | 6 months |
| Functional Independence Assessed by Modified Rankin Scale (mRS）score | MRS score range from 0 to 6. Favourable outcome (mRS score≤2), worse outcome (mRS score>2), and death (mRS score = 6) | 3 months |
| Functional Independence Assessed by Modified Rankin Scale (mRS）score | MRS score range from 0 to 6. Favourable outcome (mRS score≤2), worse outcome (mRS score>2), and death (mRS score = 6) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbial composition and diversity | Results of fecal bacteria by 16s RNA sequencing | First stool after admission |
| Serum metabolites of gut microbiota | Serum metabolites of gut microbiota from stool, detected by liquid chromatography-mass spectrometry (LC-MS) combined technique |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with ischemic stroke within 7 days of onset
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang Wei, Master | Contact | 15162113531 | neurodoc0708@126.com | |
| Hua Fang, PhD | Contact | 15252144898 | huafang@xzmc.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chen Renguo, Master | The Affiliated Hospital of Xuzhou Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | 221002 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Faecal samples
| 7 days within stroke onset |
| Serum inflammatory cytokines | Inflammatory cytokines in blood，detected by flow cytometry | 7 days within stroke onset |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |