Mild Cognitive ImpairmentMiaGBNCT07799402
Microbiome in Aging of Gut and Brain
An observational study of Mild Cognitive Impairment and Alzheimer Disease (AD), run by University of South Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease (AD), Dementia
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2021to Sep 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population includes young healthy adults aged 18-60 years and adults aged 60 years and older who are cognitively healthy or have mild cognitive impairment (MCI) or Alzheimer's disease/related dementia. Participants are recruited from participating clinical sites, memory and behavioral health clinics, senior living communities, and the community. The planned enrollment is 700 participants: 100 young healthy adults, 300 cognitively healthy older adults, 200 participants with MCI, and 100 participants with Alzheimer's disease/related dementia.
Who may be able to join
- Age 18-60 years for young healthy participants, or age 60 years and older for older adult participants.
- Participants meeting one of the following cognitive categories:
- Normal cognitive function
- Mild cognitive impairment (MCI)
- Alzheimer's disease or Alzheimer's disease-related dementia
- Able to participate in the informed consent process as applicable.
- For participants unable to provide informed consent because of cognitive impairment, consent may be obtained from a legally authorized representative (LAR) according to the approved protocol.
Who cannot join
- History of brain or gastrointestinal surgery within the past 5 years.
- History of cancer and/or cancer treatment within the past 5 years, except non-melanoma skin cancer.
- History of systemic cancer treatment within the past 5 years.
- Neurological disorders including epilepsy, Parkinson's disease, or amyotrophic lateral sclerosis.
- Antibiotic use within the past 30 days.
- Diarrhea, vomiting, and/or food poisoning within the past 30 days.
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- History of inflammatory bowel disease.
- Body mass index (BMI) greater than 45 kg/m² or less than 18 kg/m².
- Weight loss of more than 10 pounds within the past 2 weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Department of Neurosurgery and Brain and Spine and Faculty of USF Center for Microbiome Re-search, Microbiomes Institute
Tampa, Florida, 33612
Hariom Yadav, PhD, 8139748222, hyadav@usf.edu
Shalini Jain, PhD, jains10@usf.edu
About this study
Official title: Microbiome in Aging Gut and Brain (MiaGB) Study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease (AD), Dementia
- Keywords
- Gut microbiome, Oral microbiome, Cognitive impairment, Cognitive decline, Mild cognitive impairment, Alzheimer's disease, Dementia, Aging, Gut-brain axis, Intestinal permeability, Inflammation, Metabolomics, Microbiome diversity
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. | |
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiome Shannon Diversity Index
Gut microbiome alpha diversity will be quantified from stool samples using the Shannon diversity index. At baseline, Shannon diversity will be assessed across young healthy adults, cognitively healthy older adults, participants with mild cognitive impairment (MCI), and participants with Alzheimer's disease/dementia. Young healthy adults, cognitively healthy older adults, and participants with MCI will also be assessed annually to evaluate longitudinal changes in gut microbiome diversity. Participants with Alzheimer's disease/dementia will undergo baseline assessment only.
Measured: Baseline for all participants and annually for up to 5 years for longitudinally followed participants
Secondary outcomes (1)
Montreal Cognitive Assessment (MoCA) Score
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). MoCA scores will be assessed at baseline across the study groups. Young healthy adults, cognitively healthy older adults, and participants with mild cognitive impairment (MCI) will also be assessed annually to evaluate longitudinal changes in cognitive function. Participants with Alzheimer's disease/dementia will undergo baseline assessment only.
Measured: Baseline for all participants and annually for up to 5 years for longitudinally followed participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start16 Sep 2021
- Primary completionSep 2031 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799402
- Sponsor's protocol ID
- STUDY002365
- Other IDs
- 22A17
- Acronym
- MiaGB
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data may be shared, including demographic characteristics, vital and anthropometric measures, dietary information, cognitive and physical function outcomes, and data associated with collected biological specimens, including oral swab, saliva, stool, urine, and blood samples. Direct identifiers and protected health information (PHI) will not be shared. Data sharing will be conducted in accordance with participant consent, applicable IRB approvals, and NIH data-sharing requirements.
Publications
Chaudhari DS, Jain S, Yata VK, Mishra SP, Kumar A, Fraser A, Kociolek J, Dangiolo M, Smith A, Golden A, Masternak MM, Holland P, Agronin M, White-Williams C, Arikawa AY, Labyak CA, Yadav H. Unique trans-kingdom microbiome structural and functional signatures predict cognitive decline in older adults. Geroscience. 2023 Oct;45(5):2819-2834. doi: 10.1007/s11357-023-00799-1. Epub 2023 May 22.
PubMed 37213047Ahmadi S, Razazan A, Nagpal R, Jain S, Wang B, Mishra SP, Wang S, Justice J, Ding J, McClain DA, Kritchevsky SB, Kitzman D, Yadav H. Metformin Reduces Aging-Related Leaky Gut and Improves Cognitive Function by Beneficially Modulating Gut Microbiome/Goblet Cell/Mucin Axis. J Gerontol A Biol Sci Med Sci. 2020 Jun 18;75(7):e9-e21. doi: 10.1093/gerona/glaa056.
PubMed 32129462Nagpal R, Mainali R, Ahmadi S, Wang S, Singh R, Kavanagh K, Kitzman DW, Kushugulova A, Marotta F, Yadav H. Gut microbiome and aging: Physiological and mechanistic insights. Nutr Healthy Aging. 2018 Jun 15;4(4):267-285. doi: 10.3233/NHA-170030.
PubMed 29951588Cattaneo A, Cattane N, Galluzzi S, Provasi S, Lopizzo N, Festari C, Ferrari C, Guerra UP, Paghera B, Muscio C, Bianchetti A, Volta GD, Turla M, Cotelli MS, Gennuso M, Prelle A, Zanetti O, Lussignoli G, Mirabile D, Bellandi D, Gentile S, Belotti G, Villani D, Harach T, Bolmont T, Padovani A, Boccardi M, Frisoni GB; INDIA-FBP Group. Association of brain amyloidosis with pro-inflammatory gut bacterial taxa and peripheral inflammation markers in cognitively impaired elderly. Neurobiol Aging. 2017 Jan;49:60-68. doi: 10.1016/j.neurobiolaging.2016.08.019. Epub 2016 Aug 31.
PubMed 27776263Vogt NM, Kerby RL, Dill-McFarland KA, Harding SJ, Merluzzi AP, Johnson SC, Carlsson CM, Asthana S, Zetterberg H, Blennow K, Bendlin BB, Rey FE. Gut microbiome alterations in Alzheimer's disease. Sci Rep. 2017 Oct 19;7(1):13537. doi: 10.1038/s41598-017-13601-y.
PubMed 29051531