Gut Microbiota and Serum Markers for Cognitive Impairment and Poor Prognosis After Ischemic Stroke
- Conditions
- Ischemic Stroke
- Registration Number
- NCT04688138
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mini-Mental State Examination 6 months after discharge A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
Montreal Cognitive Assessment 6 months after discharge A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
Gut microbiota 3 months after discharge Results of fecal bacteria by 16s RNA sequencing
- Secondary Outcome Measures
Name Time Method National Institute of Health stroke scale(NIHSS) 6 months after discharge Neurological function score scale, ranged 0-42, higher scores mean more severe neurological deficit
Short chain fatty acids 3 months after discharge A metabolites of gut microbiota from stool, detected by gas chromatography-mass spectrometry (GC-MS) combined technique
Modified Rankin Scale(mRS) 12 months after discharge A neurological function score scale ranged 0-6, higher scores mean worse neurological outcome
Trimethylamine-N-Oxide 3 months after discharge A metabolites of gut microbiota in plasm, quantified by stable isotope dilution liquid chromatography tandem mass spectrometry
Untargeted Metabolomics 3 months after discharge 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.
Trial Locations
- Locations (1)
Department of Neurology, NanFang Hospital, Southern Medical University
🇨🇳Guanzhou, Guangdong, China