Precision Probiotic Supplementation in Individuals With Mild Cognitive Impairment - Trial NCT06278688
Access comprehensive clinical trial information for NCT06278688 through Pure Global AI's free database. This phase not specified trial is sponsored by National Yang Ming University and is currently Not yet recruiting. The study focuses on Mild Cognitive Impairment. Target enrollment is 120 participants.
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Study Focus
Sponsor & Location
National Yang Ming University
Timeline & Enrollment
N/A
Mar 18, 2024
Jul 31, 2027
Primary Outcome
The changes in attention,The changes in memory,The changes in executive function
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, i.e., 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-ฮฑ), interleukin (IL)-6 and IL-10, and increased brain-
 derived neurotrophic factor, short-chain fatty acid, etc.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06278688
Non-Device Trial