Gut Microbiota and Serum Markers for Cognitive Impairment and Poor Prognosis After Ischemic Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Predictive Value of Gut Microbiota and Serum Markers for Cognitive Impairment and Poor Prognosis After Ischemic Stroke: A Multiple Center Cohort Study

Conditions
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Ischemic Stroke

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ischemic stroke<br>Patients with ischemic stroke within 7 days of onset | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Mental State Examination | A cognitive function screening test ranged 0-30, higher scores mean better cognitive function | 7 days after admission | 
| Mini-Mental State Examination | A cognitive function screening test ranged 0-30, higher scores mean better cognitive function | 3 months after discharge | 
| Mini-Mental State Examination | A cognitive function screening test ranged 0-30, higher scores mean better cognitive function | 6 months after discharge | 
| Montreal Cognitive Assessment | A cognitive function screening test ranged 0-30, higher scores mean better cognitive function | 7 days after admission | 
| Montreal Cognitive Assessment | A cognitive function screening test ranged 0-30, higher scores mean better cognitive function | 3 months after discharge | 
| Montreal Cognitive Assessment | A cognitive function screening test ranged 0-30, higher scores mean better cognitive function | 6 months after discharge | 
| Gut microbiota | Results of fecal bacteria by 16s RNA sequencing | 2 days after admission | 
| Gut microbiota | Results of fecal bacteria by 16s RNA sequencing | 3 months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale(mRS) | A neurological function score scale ranged 0-6, higher scores mean worse neurological outcome | 7 days after admission | 
| Modified Rankin Scale(mRS) | A neurological function score scale ranged 0-6, higher scores mean worse neurological outcome | 3 months after discharge | 
| Modified Rankin Scale(mRS) | A neurological function score scale ranged 0-6, higher scores mean worse neurological outcome | 6 months after discharge | 
| Modified Rankin Scale(mRS) | A neurological function score scale ranged 0-6, higher scores mean worse neurological outcome | 12 months after discharge | 
| National Institute of Health stroke scale(NIHSS) | Neurological function score scale, ranged 0-42, higher scores mean more severe neurological deficit | Day 1 of admission | 
| National Institute of Health stroke scale(NIHSS) | Neurological function score scale, ranged 0-42, higher scores mean more severe neurological deficit | Day 7 of admission | 
| National Institute of Health stroke scale(NIHSS) | Neurological function score scale, ranged 0-42, higher scores mean more severe neurological deficit | 3 months after discharge | 
| National Institute of Health stroke scale(NIHSS) | Neurological function score scale, ranged 0-42, higher scores mean more severe neurological deficit | 6 months after discharge | 
| Short chain fatty acids | A metabolites of gut microbiota from stool, detected by gas chromatography-mass spectrometry (GC-MS) combined technique | 2 days after admission | 
| Short chain fatty acids | A metabolites of gut microbiota from stool, detected by gas chromatography-mass spectrometry (GC-MS) combined technique | 3 months after discharge | 
| Trimethylamine-N-Oxide | A metabolites of gut microbiota in plasm, quantified by stable isotope dilution liquid chromatography tandem mass spectrometry | 2 days after admission | 
| Trimethylamine-N-Oxide | A metabolites of gut microbiota in plasm, quantified by stable isotope dilution liquid chromatography tandem mass spectrometry | 3 months after discharge | 
| Untargeted Metabolomics | Untargeted metabolomics refers to using gas chromatography-mass spectrometry (GC-MS) combined technique, without bias detection of all small molecule metabolites in plasma (mainly the relative molecular weight of 1000 Da endogenous small molecule compounds) levels. | 2 days after admission | 
| Untargeted Metabolomics | Untargeted metabolomics refers to using gas chromatography-mass spectrometry (GC-MS) combined technique, without bias detection of all small molecule metabolites in plasma (mainly the relative molecular weight of 1000 Da endogenous small molecule compounds) levels. | 3 months after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic Stroke; cognitive impairment; gut microbiota