Intervention of Intestinal Microorganism in Mild Cognitive Impairment

NCT ID: NCT03991195

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-31
• Study Completion Date: 2022-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Probiotic supplemented group with aMCI

Thirty participants in this group will take Bifidobacterium for three months.

Group Type: EXPERIMENTAL

Probiotic supplemented intervention

Intervention Type: DIETARY_SUPPLEMENT

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.

Placebo group with aMCI

Thirty participants in this group will take placebo for three months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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 0.5.
• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Hospital of Tsinghua University

OTHER

Sponsor Role: collaborator

Beijing Normal University

OTHER

Sponsor Role: collaborator

XuanwuH 2

OTHER

Sponsor Role: lead

Responsible Party

XuanwuH 2

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ying Han, PhD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital of Capital Medical University

Locations

Department of Neurolgy, Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

HanYingsc

Identifier Type: -

Identifier Source: org_study_id