MiaGBGut and Oral Microbiome's Role in Cognitive Health and Decline
This observational study aims to assess the diversity of gut microbiome in different groups including young healthy adults, cognitively healthy older adults, individuals with mild cognitive impairment, and those with Alzheimer's disease/dementia, using stool samples. The study will also track annual changes in gut microbiome diversity for some groups.
Data Collection
Collected from today forward - ProspectiveMental Disorders+11
+ Brain Diseases
+ Central Nervous System Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: September 16, 2021
Actual date on which the first participant was enrolled.The Microbiome in Aging Gut and Brain (MiaGB) Study is a multisite observational study investigating relationships among the gut and oral microbiome, cognitive function, microbial metabolites, intestinal permeability, inflammation, and other biological characteristics associated with aging and cognitive impairment. The study consists of two interconnected phases. Phase 1 is a baseline cross-sectional assessment. A total of 700 participants are planned, including 100 young healthy adults, 300 cognitively healthy older adults, 200 older adults with mild cognitive impairment (MCI), and 100 older adults with Alzheimer's disease or related dementia. Baseline assessments include demographic and medical history information, cognitive function, dietary information, and selected physical function assessments. Biological samples may include stool, oral swabs, saliva, blood, and urine. Laboratory analyses may include characterization of the gut and oral microbiome, metabolomics, markers of intestinal permeability and inflammation, proteomics, transcriptomics, genetic analyses, mitochondrial function, immunophenotyping, and other protocol-specified biological assessments. These data will be examined to determine whether microbial and biological patterns differ among participants with different levels of cognitive function. Phase 2 is a prospective longitudinal follow-up. Young healthy adults, cognitively healthy older adults, and participants with MCI will be reassessed approximately annually for up to 5 years. Longitudinal assessments will be used to evaluate whether changes in the microbiome and related biological measures are associated with changes in cognitive function and whether these measures may help identify individuals at increased risk of cognitive decline. Participants with Alzheimer's disease or related dementia will undergo baseline assessment only and will not participate in the 5-year longitudinal follow-up. This is an observational study. Participants are not assigned to a drug, biological product, behavioral treatment, or other research intervention.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.700 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department of Neurosurgery and Brain and Spine and Faculty of USF Center for Microbiome Re-search, Microbiomes Institute
Tampa, United StatesOpen Department of Neurosurgery and Brain and Spine and Faculty of USF Center for Microbiome Re-search, Microbiomes Institute in Google Maps