Gut and Oral Microbiome and Cognitive Health in Aging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The MiaGB study is an observational, multisite project exploring how gut and oral microbiomes, their metabolites, and markers of inflammation relate to cognitive function and aging. It includes young adults, cognitively healthy older adults, older adults with mild cognitive impairment, and those with Alzheimer's disease or related dementia. At baseline, participants provide medical history, cognitive and physical assessments, diet information, and biological samples such as stool, saliva, oral swabs, blood, and urine; lab analyses will characterize the microbiome, metabolites, intestinal permeability, and immune markers. Participants in the younger and older healthy groups, as well as those with MCI, will be followed annually for up to five years to observe changes over time. The study comprises a cross-sectional phase and a longitudinal follow-up phase to identify microbial and biological patterns associated with cognitive status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Where it's running

• Department of Neurosurgery and Brain and Spine and Faculty of USF Center for Microbiome Re-search, Microbiomes Institute
  Tampa, Florida, United States Recruiting

Study contacts

• Study coordinator: Shalini Jain, PhD
• Email: jains10@usf.edu
• Phone: 813-974-8222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.