Intervention of Intestinal Microorganism in Mild Cognitive Impairment

July 12, 2022 updated by: XuanwuH 2

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Department of Neurolgy, Xuanwu Hospital of Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Probiotic supplemented group with aMCI
Thirty participants in this group will take Bifidobacterium for three months.
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.
PLACEBO_COMPARATOR: Placebo group with aMCI
Thirty participants in this group will take placebo for three months.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of Montreal cognitive assessment (MoCA)
Time Frame: 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.
Three months
Improvement of Auditory Verbal Learning Test (AVLT)
Time Frame: 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.
Three months
Changes of intestinal microbial flora diversity
Time Frame: 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.
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Structural MRI-based brain network changes
Time Frame: Three months
After intervention for three months, the investigators will compare the structural changes of brain network among three groups (e.g., efficiency, clustering, modularity) in order to reveal the regulatory mechanism of intestinal microorganism in intervening aMCI.
Three months
Functional MRI-based brain network changes
Time Frame: Three months
After intervention for three months, the investigators will compare the functional changes of brain network among three groups (e.g., functional connectivity, hub) in order to reveal the regulatory mechanism of intestinal microorganism in intervening aMCI.
Three months
FNIRS-based brain network changes
Time Frame: Three months
After intervention for three months, the investigators will compare the functional changes of brain network among three groups (e.g., functional connectivity, small word, efficiency) in order to reveal the regulatory mechanism of intestinal microorganism in intervening aMCI.
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XuanwuH 2

Collaborators

Beijing Normal University
First Hospital of Tsinghua University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 31, 2019

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

March 31, 2022

Study Registration Dates

First Submitted

April 28, 2019

First Submitted That Met QC Criteria

June 16, 2019

First Posted (ACTUAL)

June 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 12, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HanYingsc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The information of neuropsychological tests, neuroimaging data are to be shared with other researchers.

IPD Sharing Time Frame

When summary data are published or starting 6 months after publication.

IPD Sharing Access Criteria

The information of neuropsychological tests, neuroimaging data will be shared.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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