Microbiome in Aging of Gut and Brain
Recruiting · NCT07799402 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial 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.
Who can take part
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 is running
1 location listed across 1 US state.
- Department of Neurosurgery and Brain and Spine and Faculty of USF Center for Microbiome Re-search, Microbiomes Institute - Tampa, Florida, United States