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

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Ischemic Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT04688138

NFEC-2020-169

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 1 patient group

ischemic stroke

Description:

Patients with ischemic stroke within 7 days of onset