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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04978701
• Other study ID #: NFEC-2021-220
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2021
• Source: Nanfang Hospital of Southern Medical University
• Contact: Yin Jia, Master
• Phone: +86 13802964883
• Email: jiajiayin[@]139.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
China	Department of Neurology, NanFang Hospital, Southern Medical University	Guanzhou	Guangdong

Sponsors (8)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Guangdong Yanling Hospital, Huzhou Central Hospital, Zhejiang Province, People's Hospital of Leshan, Sichuan Province, Shenzhen University General Hospital, The First Hospital Of Qiqihar, Zhejiang Greentown Cardiovascular Hospital, Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Scale	An evaluation of neurological deficits	3 months after the onset
Primary	National Institute of Health stroke scale	An evaluation of neurological deficits	3 months after the onset
Primary	Major ischemic events	Major ischemic event is defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event.	within 3 months
Secondary	modified Rankin Scale	An evaluation of neurological deficits	6 months after the onset
Secondary	National Institute of Health stroke scale	An evaluation of neurological deficits	6 months after the onset
Secondary	Major ischemic events	Major ischemic event is defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event.	within 6 months
Secondary	modified Rankin Scale	An evaluation of neurological deficits	12 months after the onset
Secondary	National Institute of Health stroke scale	An evaluation of neurological deficits	12 months after the onset
Secondary	Major ischemic events	Major ischemic event is defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event.	within 12 months