Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278688
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-26
First Post:
2023-11-13
Brief Title:
Precision Probiotic Supplementation in Individuals With Mild Cognitive Impairment
Sponsor:
National Yang Ming Chiao Tung University
Organization:
National Yang Ming Chiao Tung University
Study Overview
Official Title:
Precision Probiotic Supplementation in Individuals With Mild Cognitive Impairment a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
None
Brief Summary:
The overarching goal of this randomized-controlled trial is to investigate the role and mechanism of the microbiota-gut-brain axis in MCI The main questions it aims to answer are
Aim 1 To investigate the association between gut microbiota MCI and AD biomarkers Investigators plan to compare gut microbiota profiles in a well-characterized cohort between individuals with MCI and cognitively normal adults using metagenomics sequencing data Also the relationship between gut microbiota and AD biomarkers such as amyloid PET and plasma tau will be explored in MCI and cognitively normal adults
Aim 2 To determine the efficacy of precision probiotic supplementation on cognitive decline primary outcome and functional brain changes secondary outcome in individuals with MCI due to AD using a randomized double-blind placebo-controlled trial Investigators plan to recruit 120 individuals with MCI due to AD ie MCI with positive amyloid biomarkers Participants will be randomized to a 12-month supplement of precision probiotics based on the individual gut probiotic profile or placebo The primary outcome measure will be the changes in cognitive functions over 6 months primary endpoint and 12 months The secondary outcome measure will be resting-state functional brain changes
Aim 3 To investigate potential mediators underlying the effect of probiotic supplementation The most apparent mediator will be a shift or changes in gut microbiota Other potential mediators will be related to decreased lipopolysaccharide proinflammatory cytokines such as tumor necrosis factor-alpha TNF-α interleukin IL-6 and IL-10 and increased brain- derived neurotrophic factor short-chain fatty acid etc
Aim 1 To investigate the association between gut microbiota MCI and AD biomarkers Investigators plan to compare gut microbiota profiles in a well-characterized cohort between individuals with MCI and cognitively normal adults using metagenomics sequencing data Also the relationship between gut microbiota and AD biomarkers such as amyloid PET and plasma tau will be explored in MCI and cognitively normal adults
Aim 2 To determine the efficacy of precision probiotic supplementation on cognitive decline primary outcome and functional brain changes secondary outcome in individuals with MCI due to AD using a randomized double-blind placebo-controlled trial Investigators plan to recruit 120 individuals with MCI due to AD ie MCI with positive amyloid biomarkers Participants will be randomized to a 12-month supplement of precision probiotics based on the individual gut probiotic profile or placebo The primary outcome measure will be the changes in cognitive functions over 6 months primary endpoint and 12 months The secondary outcome measure will be resting-state functional brain changes
Aim 3 To investigate potential mediators underlying the effect of probiotic supplementation The most apparent mediator will be a shift or changes in gut microbiota Other potential mediators will be related to decreased lipopolysaccharide proinflammatory cytokines such as tumor necrosis factor-alpha TNF-α interleukin IL-6 and IL-10 and increased brain- derived neurotrophic factor short-chain fatty acid etc
Detailed Description:
Given the rapidly aging trend worldwide and in Taiwan the disease burden and economic impact of dementia on families healthcare systems and society are expected to increase unprecedentedly It is estimated that interventions that could delay the clinical onset of dementia by a modest one year would significantly reduce the prevalence of dementia Mild cognitive impairment MCI presents an early stage of cognitive impairment with a much higher risk of progression to dementia and a unique stage potentially amenable to intervention preventing further decline to dementia
The microbiota-gut-brain axis is one of the most-studied gut-organ systems and accumulating evidence shows gut microbiota might play a critical role in the pathogenesis of Alzheimers disease AD However the role of gut microbiota in the early stage of the AD spectrum such as MCI is unclear Also the effects of the probiotic supplements on cognition in patients with AD or MCI from several small randomized-controlled trials were inconsistent Fixed regimens of probiotics were used in all these trials and patients with MCI diagnosed by diverse research frameworks were included As a result the overarching goal of this proposal is to investigate the role and mechanism of the microbiota-gut-brain axis in MCI Investigators will use data from a well-characterized cohort and a randomized controlled trial with a precision probiotic supplementation ie a probiotic supplement based on individual gut probiotic profile in a group of MCI due to AD ie MCI with positive amyloid biomarkers
The microbiota-gut-brain axis is one of the most-studied gut-organ systems and accumulating evidence shows gut microbiota might play a critical role in the pathogenesis of Alzheimers disease AD However the role of gut microbiota in the early stage of the AD spectrum such as MCI is unclear Also the effects of the probiotic supplements on cognition in patients with AD or MCI from several small randomized-controlled trials were inconsistent Fixed regimens of probiotics were used in all these trials and patients with MCI diagnosed by diverse research frameworks were included As a result the overarching goal of this proposal is to investigate the role and mechanism of the microbiota-gut-brain axis in MCI Investigators will use data from a well-characterized cohort and a randomized controlled trial with a precision probiotic supplementation ie a probiotic supplement based on individual gut probiotic profile in a group of MCI due to AD ie MCI with positive amyloid biomarkers
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