Clinical trial NCT04688138: Gut Microbiota and Serum Markers for Cognitive Impairment and Poor Prognosis After Ischemic Stroke
Official title: Predictive Value of Gut Microbiota and Serum Markers for Cognitive Impairment and Poor Prognosis After Ischemic Stroke: A Multiple Center Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Keywords: Ischemic Stroke; cognitive impairment; gut microbiota
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Guangdong 999 Brain Hospital
name: Zhujiang Hospital
name: First Affiliated Hospital of Jinan University
First posted: 2020-12-29
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ischemic stroke within 7 days of onset

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mini-Mental State Examination
timeFrame: 7 days after admission
measure: Mini-Mental State Examination
timeFrame: 3 months after discharge
measure: Mini-Mental State Examination
timeFrame: 6 months after discharge
measure: Montreal Cognitive Assessment
timeFrame: 7 days after admission
measure: Montreal Cognitive Assessment
timeFrame: 3 months after discharge
measure: Montreal Cognitive Assessment
timeFrame: 6 months after discharge
measure: Gut microbiota
timeFrame: 2 days after admission
measure: Gut microbiota
timeFrame: 3 months after discharge
Secondary outcomes:
measure: Modified Rankin Scale(mRS)
timeFrame: 7 days after admission
measure: Modified Rankin Scale(mRS)
timeFrame: 3 months after discharge
measure: Modified Rankin Scale(mRS)
timeFrame: 6 months after discharge
measure: Modified Rankin Scale(mRS)
timeFrame: 12 months after discharge
measure: National Institute of Health stroke scale(NIHSS)
timeFrame: Day 1 of admission
measure: National Institute of Health stroke scale(NIHSS)
timeFrame: Day 7 of admission
measure: National Institute of Health stroke scale(NIHSS)
timeFrame: 3 months after discharge
measure: National Institute of Health stroke scale(NIHSS)
timeFrame: 6 months after discharge
measure: Short chain fatty acids
timeFrame: 2 days after admission
measure: Short chain fatty acids
timeFrame: 3 months after discharge
measure: Trimethylamine-N-Oxide
timeFrame: 2 days after admission
measure: Trimethylamine-N-Oxide
timeFrame: 3 months after discharge
measure: Untargeted Metabolomics
timeFrame: 2 days after admission
measure: Untargeted Metabolomics
timeFrame: 3 months after discharge
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Department of Neurology, NanFang Hospital, Southern Medical University
state: Guangdong
Study officials:
References: