NCT03991195

Intervention of Intestinal Microorganism in Mild Cognitive Impairment

Regulatory Mechanism of Intestinal Microorganism in Intervening Mild Cognitive Impairment Based on Multi-modal Neuroimaging Techniques

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: XuanwuH 2 · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gut Microbiota
• Mild Cognitive Impairment
• Dementia, Alzheimer Type
• Neuroimaging

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic supplemented intervention	In this project, taking the method of random, double blindness and control, the probiotic supplemented group with aMCI will take Bifidobacterium for three months. After that, cognitive changes will be test to investigate the effectiveness of probiotic supplementation.
DIETARY_SUPPLEMENT	Placebo	In this project, taking the method of random, double blindness and control, the placebo group with aMCI will take placebo for three months. After that, cognitive changes will be test.

Timeline

• Start date: 2019-08-31
• Primary completion: 2021-12-31
• Completion: 2022-03-31
• First posted: 2019-06-19
• Last updated: 2022-07-13

Locations

1 site across 1 country: China