Exploring how the human microbiome can predict outcomes in acute ischemic stroke patients
Dynamic Changes in Human Microbiome Predict the Risk of Adverse Outcomes in Patients With Acute Ischemic Stroke: a Multicenter Prospective Cohort Study
This study is trying to see if the bacteria in our bodies can help predict how well people with acute ischemic stroke will recover and if they might face any emotional or thinking problems afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06240468 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective cohort study aims to investigate the predictive value of the human microbiome and its metabolites for adverse outcomes in patients with acute ischemic stroke (AIS). A total of 2000 AIS patients will be enrolled, with neurological function scores evaluated during and after hospitalization. Biological samples, including blood, urine, feces, and periodontal swabs, will be collected at multiple time points to analyze changes in the microbiome and their correlation with stroke prognosis. The study also seeks to identify markers related to cognitive and emotional complications following stroke.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 who have been diagnosed with acute ischemic stroke or transient ischemic attack within 7 days of onset.
Not a fit: Patients with recurrent strokes within the past year or significant pre-existing health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new predictive tools for assessing the risk of adverse outcomes in stroke patients based on their microbiome.
How similar studies have performed: While the relationship between the microbiome and various health outcomes is being explored, this specific approach in acute ischemic stroke is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meet the diagnostic criteria for AIS or TIA * Age 18-80 years old * Within 7 days of the onset of stroke * Sign informed consent, provide relevant medical history and biological specimens * Have lived in the local city for the last three years Exclusion Criteria: * Patients with recurrent stroke within the past year when first enrolled * mRS \> 2 points before stroke onset * malignant tumor * Liver and kidney dysfunction (alanine aminotransferase or aspartate aminotransferase \>2 times the upper limit of normal, creatinine \> 1.5 times the upper limit of normal) * History of drug abuse and chemical poisoning (e.g. pesticide poisoning) * In the acute stage of stroke (within 7 days from the onset of stroke) stool specimens could not be collected
Where this trial is running
Guangzhou, Guangdong
- Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Mengxi Li
- Email: 1135621389@qq.com
- Phone: 15013048680
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.