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Microbiome in Aging of Gut and Brain

University of South Florida · NCT07799402

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
700
US sites recruiting
1
Study start
September 16, 2021
Record last updated
September 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Conditions: Mild Cognitive Impairment; Alzheimer Disease (AD); Dementia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Department of Neurosurgery and Brain and Spine and Faculty of USF Center for Microbiome Re-search, Microbiomes Institute

    Tampa, FL 33612

    Site contact: Hariom Yadav, PhD · 8139748222 · hyadav@usf.edu

Study contacts (from the official record)

  • Shalini Jain, PhD · 813-974-8222 · jains10@usf.edu
All neurology studies in Florida →
Microbiome in Aging of Gut and Brain (NCT07799402) | Bored Studies