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Microbiome in Aging of Gut and Brain

Microbiome in Aging Gut and Brain (MiaGB) Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Young healthy adults, cognitively healthy older adults, and participants with MCI will be reassessed approximately annually for up to 5 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether tiny living things in the gut and mouth are linked to memory and thinking skills and how those skills change. It includes healthy adults ages 18–60 and adults ages 60 and older with normal thinking skills, mild thinking problems, or Alzheimer's disease or related dementia. No study drug or treatment is given.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be ages 18–60 for the young healthy group, or age 60 or older for an older adult group.
  • Have normal memory and thinking skills, mild cognitive impairment (mild memory or thinking problems), or Alzheimer's disease or related dementia.
  • Be able to take part in the study consent process. If thinking problems prevent you from giving consent, a legally authorized person may give consent for you under the study rules.

Who can't join

  • Brain or digestive tract surgery in the past 5 years.
  • Cancer or cancer treatment in the past 5 years, except non-melanoma skin cancer. Cancer treatment that affects the whole body in the past 5 years also excludes you.
  • A brain or nerve disorder such as epilepsy (a seizure disorder), Parkinson's disease, or ALS (a disease that weakens muscles).
  • Antibiotic use in the past 30 days.
  • Diarrhea, vomiting, or food poisoning in the past 30 days.
  • A history of inflammatory bowel disease, which causes swelling in the digestive tract.
  • Body mass index (BMI), a measure of weight compared with height, above 45 or below 18.
  • Loss of more than 10 pounds in the past 2 weeks.

Simplified for readability. The official criteria below are what the study team uses.

Official 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-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.

Study sites (1)

FL