Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06039267
Status:
RECRUITING
Last Update Posted:
2023-09-15
First Post:
2023-08-31
Brief Title:
Brain Health the Microbiome
Sponsor:
George Washington University
Organization:
George Washington University
Study Overview
Official Title:
Brain Health the Microbiome A Proof-of-Concept Study in Patients With Mild Cognitive Impairment
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
bMicrobiome
Brief Summary:
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 Alzheimers 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 andor may slow or halt the progression of MCI or early Alzheimers
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 Hills criteria for causality 1 This means we will begin to investigate causality using one of Hills 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 phylumgenus 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 MCIAD 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
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 phylumgenus 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 MCIAD 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None