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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04978701

Enrollment

2000

Registered

2021-07-27

Start date

2021-08-01

Completion date

2025-06-30

Last updated

2021-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic stroke, microbiome, prognosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
modified Rankin Scale	3 months after the onset	An evaluation of neurological deficits
National Institute of Health stroke 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

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

Countries

China

Contacts

Primary ContactYin Jia, Master

jiajiayin@139.com+86 13802964883

Backup ContactZhang Mingsi, Master

meens19@qq.com+86 13827003570

Outcome results