Dynamic Changes of the Human Microbiome Predict the Risk of Poor Prognosis in Patients With Acute Ischemic Stroke: a Multi-center Study

Study Overview
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Brief Summary
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Recent studies have found a close relationship between acute ischemic stroke(AIS) and gut microbiota, but whether the dynamic changes in human microbiome after stroke can predict poor prognosis of stroke remains unclear. Therefore, we planned to explore the predictive value of human microbiome and its metabolites in stroke prognosis through a multicenter cohort study

Detailed Description
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This study was designed as a prospective, observational, multicenter cohort study. 2000 patients with AIS will be enrolled continuously through multiple centers. Oral swabs, feces (the day after admission, 1 month, 3 months after the onset of disease) and blood samples (the day after admission, 3 months after the onset of disease) will be collected. After the onset of the disease (1 month, 3 months, 6 months and 12 months), outpatient/telephone follow-up will be conducted to evaluate the neurological function scores of the patients, and the recurrence of stroke and other cardio-cerebrovascular events will be recorded.

Official Title
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Dynamic Changes of the Human Microbiome Predict the Risk of Poor Prognosis in Patients With Acute Ischemic Stroke: a Multi-center Study

Conditions
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Acute Ischemic Stroke

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the AIS diagnostic criteria; Age 18-80; Within 7 days of the onset; Signing the informed consent, providing relevant medical history and biological specimens. Exclusion Criteria: mRS > score 2 before onset; Serious systemic diseases including malignant tumors; Hematological diseases and autoimmune diseases; ALT or AST > 2 times the upper limit of normal value or severe liver disease; Serum creatinine > 1.5 times the upper normal limit or severe nephropathy; History of alcoholism, drug abuse, and chemical poisoning (e.g. pesticide poisoning); History of intestinal tumor, irritable bowel syndrome or inflammatory bowel disease or confirmed in hospital; Antibiotic use within 1 month before admission; Fece cannot be obtained within 4 days after admission.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin Scale | An evaluation of neurological deficits | 3 months after the onset | 
| National Institute of Health stroke scale | An evaluation of neurological deficits | 3 months after the onset | 
| Major ischemic events | Major ischemic event is defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event. | within 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin Scale | An evaluation of neurological deficits | 6 months after the onset | 
| National Institute of Health stroke scale | An evaluation of neurological deficits | 6 months after the onset | 
| Major ischemic events | Major ischemic event is defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event. | within 6 months | 
| modified Rankin Scale | An evaluation of neurological deficits | 12 months after the onset | 
| National Institute of Health stroke scale | An evaluation of neurological deficits | 12 months after the onset | 
| Major ischemic events | Major ischemic event is defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event. | within 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute ischemic stroke, microbiome, prognosis