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

Recruiting

• Conditions: Acute Ischemic Stroke

• Registration Number: NCT04978701
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-27
• Study Start: 2021-08-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-11
• Last Update Posted: 2021-11-12
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
National Institute of Health stroke scale	3 months after the onset	An evaluation of neurological deficits
modified Rankin Scale	3 months after the onset	An evaluation of neurological deficits
Major ischemic events	within 3 months	Major ischemic event is defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event.

Secondary Outcome Measures

Name	Time	Method
Major ischemic events	within 12 months	Major ischemic event is defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event.
modified Rankin Scale	12 months after the onset	An evaluation of neurological deficits
National Institute of Health stroke scale	12 months after the onset	An evaluation of neurological deficits

Trial Locations

Locations (1)

Department of Neurology, NanFang Hospital, Southern Medical University; 🇨🇳 Guanzhou, Guangdong, China