Microbiome in Aging of Gut and Brain

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT07799402
Status
Recruiting
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Conditions

  • Alzheimer Disease (AD)
  • Dementia
  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

The Microbiome in Aging Gut and Brain (MiaGB) Study is an observational study designed to examine whether differences in the microorganisms living in the gut and mouth are associated with cognitive health and cognitive decline. The study includes young healthy adults, cognitively healthy older adults, older adults with mild cognitive impairment (MCI), and older adults with Alzheimer's disease or related dementia. At the baseline visit, participants complete assessments of medical history, cognitive function, physical function, and diet and provide biological samples that may include stool, saliva, oral swabs, blood, and urine. Researchers will study the gut and oral microbiome and related biological factors, including metabolites and markers of intestinal permeability and inflammation, to determine whether these measures differ according to cognitive status. Young healthy adults, cognitively healthy older adults, and participants with MCI will be followed annually for up to 5 years to evaluate changes in the microbiome and cognitive function over time. Participants with Alzheimer's disease or related dementia will participate in the baseline assessment only. No drug, treatment, or other research intervention is assigned as part of this study.

Key Dates

First listed
Sep 2, 2026
Start date
Sep 16, 2021
Status verified
Aug 2026
Primary completion
Sep 30, 2031
Completion
Sep 30, 2031

Study Design

Enrollment
700 participants (estimated)

Arms

  • Arm: Young Healthy Adults
    Healthy adults aged 18-60 years with normal cognitive function. Participants undergo baseline assessments and annual follow-up for up to 5 years.
  • Arm: Cognitively Healthy Older Adults
    Adults aged 60 years and older with normal cognitive function. Participants undergo baseline assessments and annual follow-up for up to 5 years.
  • Arm: Mild Cognitive Impairment (MCI)
    Adults aged 60 years and older with mild cognitive impairment. Participants undergo baseline assessments and annual follow-up for up to 5 years.
  • Arm: Alzheimer's Disease/Dementia
    Adults aged 60 years and older with Alzheimer's disease or Alzheimer's disease-related dementia. Participants undergo baseline assessment only and are not included in the 5-year longitudinal follow-up.

Primary Outcome Measure

Gut Microbiome Shannon Diversity Index [ Time Frame: Baseline for all participants and annually for up to 5 years for longitudinally followed participants ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Neurosurgery and Brain and Spine and Faculty of USF Center for Microbiome Re-search, Microbiomes InstituteTampaFlorida33612
Hariom Yadav, PhD
[email protected]
8139748222
Shalini Jain, PhD
[email protected]

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By research site
Department of Neurosurgery and Brain and Spine and Faculty of USF Center for Microbiome Re-search, Microbiomes Institute· Tampa, FL

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