No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
700 (estimated)
Sponsor
University of South Florida · Other
Who this trial is looking for
This trial is looking for adults to examine how gut and mouth microorganisms relate to thinking and memory. Participants will provide samples and complete assessments, with some followed for up to 5 years.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 60 years old or 60 years and older.
I have normal cognitive function or mild cognitive impairment or Alzheimer's disease.
I am able to participate in the informed consent process.
If I can't provide consent, a legally authorized representative can do so.
You may not be able to join if
I have had brain or gastrointestinal surgery in the past 5 years.
I have had cancer or cancer treatment in the past 5 years, except non-melanoma skin cancer.
I have a neurological disorder like epilepsy or Parkinson's disease.
I have taken antibiotics in the past 30 days.
I have had diarrhea, vomiting, or food poisoning in the past 30 days.
I have a history of inflammatory bowel disease.
My body mass index (BMI) is greater than 45 or less than 18.
I have lost more than 10 pounds in the past 2 weeks.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Eligibility 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-…
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.
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