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

Nanfang Hospital, Southern Medical University

Status: Enrolling

Conditions: Acute Ischemic Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT04978701

NFEC-2021-220

Details and patient eligibility

About

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

Full description

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.