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临床试验/NCT03827733
NCT03827733Unknown不适用

Gut Microbiota and Alzheimer's Diseases

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Gut beta-amyloid 42

研究概览

简要总结

The investigator will perform clinical studies to test a hypothesis that participants who have Alzheimer's disease will have different gut/oral microbiota profile as compared to the participants who do not have Alzheimer's disease. The investigators will also check the microbiome of their partners in this study. The investigators plan to perform the studies in 150 participants in Shanghai Tenth's People's Hospital and also in the houses in Shanghai city. Investigators will also measure the beta-amyloid in the feces of the participants. Finally, the investigators will determine cognitive function in these participants.

详细描述

Studies have shown that gut/oral microbiome and beta-amyloid in body may have a significant impact on the behavior and brain pathology consistent with Alzheimer's disease (AD) neuropathogenesis. The objective of this study is to assess whether the gut/oral microbiome and feces beta-amyloid of AD patients are different from those of the participants without AD and their partners. The investigators plan to recruit 150 subjects, including three groups of normal elders, AD patients and the partners of the AD patients. The cognitive function will be assessed and the feces and oral samples will be collected to determine whether there are differences or correlations.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • aged 60 and older

排除标准

  • with other acute gastrointestinal diseases
  • with other severe neuropsychiatric disorders

结局指标

主要结局

Gut beta-amyloid 42

时间窗: Through study completion, an average of 4 year

Gut amyloid-beta 42 will be determined by digital ELISA, traditional ELISA and western blot.

次要结局

  • Oral microbiota(Through study completion, an average of 4 year)
  • Cognitive function by Mini-mental State Examination (MMSE)(through study completion, an average of 4 year)
  • Gut microbiota(Through study completion, an average of 4 year)

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

Yuan Shen, MD, PhD

Chief of Psychiatry Department

Shanghai 10th People's Hospital

研究点 (1)

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