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临床试验/NCT03812445
NCT03812445Unknown不适用

The Effect of Probiotics on Cognition and Gut Microbiome Associated Study of Shanghai People With Acute Ischemic Stroke

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
change from admission on gut microbiome at 3months by genome sequencing

研究概览

简要总结

The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of ischemic stroke patients.

详细描述

This study aims to detect the impact of probiotics administration during the process of ischemic stroke treatment and recovery phase. The day of admission and 3months after stroke data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the stroke patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • patients diagnosed with acute ischemic stroke on the basis of World Health Organization diagnostic criteria
  • the time from paroxysm to admission ≤2weeks.

排除标准

  • Imaging diagnoses hemorrhagic stroke Severe depression Severe disturbance of hearing vision and reading Illiteracy Have recognitive disorder before stroke (recorded in medical records) Treated with antibiotics probiotics or prebiotics in1month before admission

研究组 & 干预措施

No Intervention

No Intervention

the patients in this arm will not receive probiotics.

Experimental

Experimental

the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus for 3 months.

干预措施: Probiotics (Dietary Supplement)

结局指标

主要结局

change from admission on gut microbiome at 3months by genome sequencing

时间窗: 3months

change of the gut microbiome will be calculated at 3months in comparison with admission.

次要结局

  • change from admission on cognitive function at 3months by Montreal Cognitive Assessment.(3months)
  • change from admission on emotion at 3months by Hamilton Depression Scale.(3months)

研究者

发起方
Shanghai 10th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Huanlong Qin

DIRECTOR

Shanghai 10th People's Hospital

研究点 (1)

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