Brain Health & the Microbiome (bMicrobiome)

September 8, 2023 updated by: George Washington University

Brain Health & the Microbiome: A Proof-of-Concept Study in Patients With Mild Cognitive Impairment

The GW SMHS supports research in complementary and integrative approaches to treatment of sickness and disease and for health promotion. Sometimes, research may involve asking questions of patients, students, and health providers. In this study, individuals are being asked to participate in this study as either 1) a healthy volunteer, 2) a person with Mild Cognitive Impairment (MCI), or 3) a person with early Alzheimer's disease (eAD). We are trying to learn more about if the gut microbiome (the microbes that live in our digestive tract) of individuals with eAD, MCI, and healthy controls are altered following lifestyle changes. This research will provide the pilot data to begin to understand if these changes in the gut microbiome are beneficial to health and/or may slow or halt the progression of MCI or early Alzheimer's.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

AD is, in a word, devastating. The massive psychological and physical trauma experienced by people with dementia and their loved ones is catastrophic and incapable of overestimation. It is incumbent upon researchers and clinicians to not only better understand the etiology of this disease, but also to translate this knowledge into actionable evidence to facilitate clinical care and prevention. The MGBA serves as a major etiological factor, in both cause and potentiation of the disease process, that possesses great potential for intervention. Interventions have the greatest opportunity for success earlier in the disease pathogenesis; therefore, MCI is an ideal target for intervention to prevent progression to AD. To effectively apply knowledge of this bidirectional relationship, a clearer picture of dysbiosis relevant to cognitive decline must be identified. The inclusion of HC, MCI, and early AD allows for the detection of a dose-response relationship, which is one of Bradford Hill's criteria for causality. 1 This means we will begin to investigate causality (using one of Hill's eight criteria) in addition to association in this proof-of-concept study.

Most previous research has been done at too high a phylogenetic level to be truly informative in terms of interventions-in other words the data is too low resolution. The microbiome field was launched at the phylum/genus level for many reasons including the need to start somewhere in such a complex system. To put this in perspective, comparing a genus, such as Lactobacillus, would be akin to comparing a compilation or average of all species of the genus Homo: H. sapiens, H. habilis, H. errectus, H. heigelbergensis, H. neanderthalensis, and H. naledi. The diversity in Homo sapiens alone is staggering. How could we possibly think this is specific or high resolution enough to be clinically meaningful? Well, the research has shown that it is not. This coupled with advancements in technology (qPCR to 16S to shotgun metagenomics) has changed the landscape of the microbiome field. However, such advanced testing and understanding has yet to make it to the clinic and has largely not been applied to MCI or AD populations to date.

The sum of the evidence suggests that restoration of the gut microbiome may serve to prevent, slow, or even reverse MCI/AD. Whether this entails the use of diet, supplements, medications, etc. or some combination thereof remains to be discovered. Before an intervention can be designed, a firm grasp of the specific alterations to the gut microbiome must be identified using higher resolution than simply genus alone-we must understand species level at least, ideally strain level in many cases. Once we understand the species-level alterations, therapeutic interventions may then be implemented to determine the effect size of said interventions.

Study Type

Observational

Enrollment (Estimated)

90

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

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Recruiting
        • George Washington University School of Medicine & Health Sciences
        • Contact:
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Residents of the greater Washington, DC Metro Area.

Description

Inclusion Criteria:

  • Age 50-90
  • Early Alzheimer's Disease (eAD)
  • Mild Cognitive Impairment (MCI)
  • Healthy Control (no eAD or MCI)

Exclusion Criteria:

  • Criteria or pathology that may affect the outcomes of the study or the risk/benefit ratio as determined by the study team

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Controls
Healthy males and females, ages 50-90
Other: Gut Microbiome Testing
Stool microbiome testing using shotgun metagenomic sequencing
Mild Cognitive Impairment
Males and females with mild cognitive impairment, ages 50-90
Other: Gut Microbiome Testing
Stool microbiome testing using shotgun metagenomic sequencing
Early Alzheimer's Disease
Males and females with early Alzheimer's disease, ages 50-90
Other: Gut Microbiome Testing
Stool microbiome testing using shotgun metagenomic sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut Microbiome Composition
Time Frame: 3- and 6-months
To compare the gut microbiomes of patients with early Alzheimer's disease, mild cognitive impairment, and healthy controls using diversity as well as genus, species, and strain level differences in composition (shotgun metagenomics).
3- and 6-months
Gut Microbiome Function
Time Frame: 3- and 6-months
To compare the gut microbiomes of patients with early Alzheimer's disease, mild cognitive impairment, and healthy controls using diversity as well as genus, species, and strain level differences in function (shotgun metagenomics).
3- and 6-months
Document microbiome changes following lifestyle changes in subjects with early Alzheimer's disease, mild cognitive impairment, and healthy controls for future study design.
Time Frame: 3- and 6-months
Observationally collect gut microbiome and lifestyle changes to inform the design of a trial to study lifestyle interventions.
3- and 6-months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut Microbiome Diversity (Index)
Time Frame: 6 months
Gut microbiome diversity (index) will exhibit a dose-response relationship among subjects with early Alzheimer's disease, mild cognitive impairment, and healthy controls.
6 months
Gut Microbiome Composition (Shotgun Metagenomics)
Time Frame: 6 months
Gut microbiome composition (shotgun metagenomics) will exhibit a dose-response relationship among subjects with early Alzheimer's disease, mild cognitive impairment, and healthy controls.
6 months
Gut Microbiome Function (Shotgun Metagenomics)
Time Frame: 6 months
Gut microbiome function (shotgun metagenomics) will exhibit a dose-response relationship among subjects with early Alzheimer's disease, mild cognitive impairment, and healthy controls.
6 months
Diet as Effect-Modifier (DietID)
Time Frame: 6 months
Implementing dietary changes (DietID) like increasing microbiota accessible carbohydrates (i.e. prebiotic dietary fiber and resistant starches) will modify the relationship between MCI status and gut microbiome composition and function, dependent upon magnitude and regularity of implementation.
6 months
Physical Activity as Effect-Modifier (Self-report)
Time Frame: 6 months
Implementing physical activity changes (self-report) will modify the relationship between MCI status and gut microbiome composition and function, dependent upon magnitude and regularity of implementation.
6 months
Probiotic as Effect-Modifier (Self-report)
Time Frame: 6 months
Taking a personalized probiotic strain (self-report) will modify the relationship between MCI status and gut microbiome composition and function, dependent upon effectiveness of the probiotic and adherence to the probiotic regimen.
6 months
Bowel Movement Position as Effect-Modifier (Self-report)
Time Frame: 6 months
Improving bowel movement position (i.e. from 90° to 35°, self-report) will modify the relationship between MCI status and gut microbiome composition and function, dependent upon regularity of implementation.
6 months

Collaborators and Investigators

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

Sponsor

George Washington University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 25, 2023

Primary Completion (Estimated)

August 24, 2024

Study Completion (Estimated)

August 24, 2024

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCR234792

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share.

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.

Clinical Trials on Mild Cognitive Impairment

Clinical Trials on Gut Microbiome Testing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe