A Study of the Relationship of Gut Microbial Composition and Stroke Outcome
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Measured differences in taxonomic make-up and the relative frequency of the gut microbial composition in relation to excellent vs. poor stroke outcome
研究概览
简要总结
The purpose of this study is to investigate the relationship between gut microbiome (bacteria in the gut), inflammation and the injured brain. It has been established that bacteria in the gut play key roles in digestion, nutrition absorption and immune response of the entire body. Human intestinal bacteria composition in the gut has been associated with several stroke risk factors including obesity, insulin resistance, diabetes and hypertension. If we can establish a relationship between gastrointestinal microbial community composition and ischemic stroke outcomes could lead to dietary interventions in the future to improve recovery after a stroke.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women at least 18 years of age.
- •Willing and able to attend all study visits.
- •English speaking.
- •Must have had a stroke that occurred within 48 hours of admission to the Stroke Unit as determined by a neurologist.
排除标准
- •History of inflammatory bowel disease.
- •Receiving antibiotics within 30 days of entry into the study.
- •History of institutionalization for mental illness within the last year.
- •Unable to consent and does not have a surrogate available to consent on their behalf.
结局指标
主要结局
Measured differences in taxonomic make-up and the relative frequency of the gut microbial composition in relation to excellent vs. poor stroke outcome
时间窗: Baseline, 3 months
The primary outcome in this case-comparison design of those with excellent vs. non-excellent ischemic stroke outcomes at 3 months as measured by the National Institutes of Health Stroke Scale (NIHSS) is the taxonomic make up of the gut microbial composition. In other words, comprehensive microbiota survey results from 16S rRNA gene sequencing from individuals with excellent outcomes versus all other outcomes at 3 months are the outcome.
次要结局
- Cogstate cognitive correlates and post-stroke microbial composition(Baseline, 3 months)