Understanding how gut bacteria changes can predict stroke outcomes
Dynamic Changes of the Human Microbiome Predict the Risk of Poor Prognosis in Patients With Acute Ischemic Stroke: a Multi-center Study
This study looks at how changes in gut bacteria can help predict recovery and future health issues in people who have had a stroke.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guanzhou, Guangdong) |
| Trial ID | NCT04978701 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between changes in the human microbiome and the prognosis of patients who have experienced an acute ischemic stroke (AIS). A total of 2000 AIS patients will be enrolled from multiple centers, with biological samples collected at various time points after stroke onset. The study will follow patients for up to 12 months to assess neurological function and the occurrence of subsequent strokes or cardiovascular events. By analyzing the microbiome and its metabolites, researchers hope to identify predictive markers for poor outcomes in stroke patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 who have been diagnosed with acute ischemic stroke within the last 7 days.
Not a fit: Patients with severe pre-existing conditions or those who have recently used antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new predictive tools for assessing stroke prognosis based on gut microbiome changes.
How similar studies have performed: While the relationship between the microbiome and stroke outcomes is being explored, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guanzhou, Guangdong
- Department of Neurology, NanFang Hospital, Southern Medical University — Guanzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Yin Jia, Master — Department of Neurology, NanFang Hospital, Southern Medical University
- Study coordinator: Yin Jia, Master
- Email: jiajiayin@139.com
- Phone: +86 13802964883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.