Regulatory Mechanism of Intestinal Microorganism in Intervening Mild Cognitive Impairment Based on Multi-modal Neuroimaging Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Improvement of Auditory Verbal Learning Test (AVLT)
研究概览
简要总结
Alzheimer's disease (AD) is the most common form of neurodegenerative disorders leading to dementia. Currently, there has been no effective drugs targeting this disease. Dysbiosis of the gut microbiota is considered to be associated with AD, and probiotic supplementation may positively affect cognitive function. However, there are few studies involving the relationship between intestinal microorganism and amnestic mild cognitive impairment (aMCI). In this project, taking the method of random, double blindness and control, the probiotic supplemented group with aMCI will take certain Bifidobacterium for a certain time. After that, the investigators aim to investigate the improvement of cognitive function and changes of intestinal microbial flora diversity via combining neuropsychological tests and 16S recombinant deoxyribonucleic acid (rDNA) high-throughput sequencing technique. Furthermore, based on the multi-modal neuroimaging techniques, the regulatory mechanism of intestinal microorganism in intervening aMCI will be revealed from the perspective of brain networks. In conclusion, these results are beneficial for understanding the therapeutic effect of gut microbiota as a non-drug treatment for early AD and further elucidating the potential brain mechanism, which are of great values in solving scientific and clinical practice issues.
详细描述
Dysbiosis of the gut microbiota is considered to be associated with Alzheimer's disease (AD), and probiotic supplementation may positively affect cognitive function for patients with AD. However, there are few existing studies involving the role of gut microbiota in possible intervention for amnestic mild cognitive impairment (aMCI).
In this project, taking the method of random, double blindness and control, the probiotic supplemented group with aMCI will take Bifidobacterium for three months. The control group with aMCI will take placebo. After that, the investigators aim to investigate the differences of cognitive function between these two groups and changes of intestinal microbial flora diversity via combining neuropsychological tests and 16S rDNA high-throughput sequencing technique. Furthermore, based on the multi-modal neuroimaging techniques, including structural magnetic resonance imaging (sMRI）, functional MRI, diffusion tensor imaging (DTI)， functional near-infrared spectroscopy (fNIRS), the regulatory mechanism of intestinal microorganism in intervening aMCI will be revealed from the perspective of brain networks.
In conclusion, these results are beneficial for understanding the therapeutic effect of gut microbiome as a non-drug treatment for early AD and further elucidating the potential brain mechanism, which are of great values in solving scientific and clinical practice issues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of patients with aMCI: memory loss complaint confirmed by an informant; objective cognitive impairment in single or multiple domains, adjusted for age and education; preserved general cognitive function; failure to meet the criteria for dementia; the clinical dementia rating (CDR) score is 0.
- •Clinical diagnosis of patients with subjective cognitive decline (SCD): presence of self-perceived continuous cognitive decline compared to previous normal status and unrelated to an acute event; failure to meet the following criteria for MCI.
- •Clinical diagnosis of the control group: no complaint of memory loss; CDR score is 0; no severe visual or auditory impairment.
排除标准
- •a history of stroke;
- •major depression (Hamilton Depression Rating Scale score > 24 points);
- •other central nervous system diseases that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis and epilepsy;
- •cognitive impairment caused by traumatic brain injury;
- •systemic diseases, such as thyroid dysfunction, syphilis and HIV;
- •a history of psychosis or congenital mental growth retardation.
结局指标
主要结局
Improvement of Auditory Verbal Learning Test (AVLT)
时间窗: Three months
After intervention for three months, the investigators will then compare cognitive changes of Auditory Verbal Learning Test (AVLT) among three groups, in order to investigate the therapeutic effectiveness of probiotic supplementation and functional foods.
Improvement of Montreal cognitive assessment (MoCA)
时间窗: Three months
After intervention for three months, the investigators first aim to compare cognitive changes of Montreal cognitive assessment (MoCA) among three groups, in order to investigate the therapeutic effectiveness of probiotic supplementation and functional foods.
Changes of intestinal microbial flora diversity
时间窗: Three months
After intervention for three months, the investigators will further compare the diversity changes of intestinal microbial flora, such as Lactobacteria species, Bifidobacterium, Enterococci, Propionobacteria, Peptostreptococci, etc., among three groups.
次要结局
- Structural MRI-based brain network changes(Three months)
- FNIRS-based brain network changes(Three months)
- Functional MRI-based brain network changes(Three months)
研究者
XuanwuH 2
Professor
Xuanwu Hospital, Beijing