跳至主要内容
临床试验/NCT05113043
NCT05113043招募中不适用

Research on Correlation Between Intestinal Microecology Imbalance and the Risk and Prognosis of Stroke in Young Adults

Shanghai 6th People's Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Modified Rankin Scale scores

研究概览

简要总结

The relationship between the intestinal microecology and stroke has become a research hotspot in neurology field today. Maintaining the balance of the intestinal microbiota are expected to bring new breakthroughs for prevention and treatment of stroke. In recent years, stroke in young adults has an increasing incidence and a considerable socioeconomic impact because of high disability rate and health-care costs. So there is an urgent need to explore the role and mechanism of intestinal microecology imbalance in stroke, especially in the development and prognosis of stroke in young people. This study aims to use multi-omics technologies, including microbial diversity, metagenomics and metabonomics, to reveal the characteristics of intestinal flora in young stroke patients, identify biomarkers for predicting outcome after stroke and early detection of young people at high risk of stroke, and to further explore the role of gut-brain axis in the pathogenesis of stroke.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of acute ischemic or hemorrhagic stroke
  • Admission within 12 hours
  • Aged 18-45 years

排除标准

  • History of neurological diseases, myocardial infarction, renal and hepatic abnormalities and metabolic diseases
  • Combined with tumors, inflammatory bowel disease and other digestive system diseases
  • Combined with serious life-threatening diseases or condition
  • Any antibiotics, probiotics or prebiotic treatment within 3 months
  • Deteriorate and die before collecting faecal samples

结局指标

主要结局

Modified Rankin Scale scores

时间窗: 3 months

0 = No symptoms; 1 = No significant disability. Able to carry out all usual activities, despite some symptoms; 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 = Moderate disability. Requires some help, but able to walk unassisted; 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 = Dead.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hao Chen, MD, PhD

Associate Clinical Professor

Shanghai 6th People's Hospital

研究点 (1)

Loading locations...

相似试验