Active not recruitingOBSERVATIONAL

Microbiome of the Ageing Gut and Its Effect on Human Gut Health and Cognition.

This study explores how the tiny living things in our gut, known as the microbiome, change as people get older. Researchers will follow 360 healthy individuals over 60 living in East Anglia for over four years. They want to see if changes in these gut microbes are connected to how our memory and thinking skills change with age. The study aims to identify early signs of memory issues related to our gut, which could help develop new ways to keep our brains healthy as we age. Participants will be grouped by their risk of developing memory problems and will involve regular check-ups and samples.

At a glance

Status

Active not recruiting

Sponsor

Quadram Institute Bioscience

Enrolment target

360

Start

01 Sep 2019

Estimated completion

01 Apr 2028

Ageing

What is this study about?

Our bodies are home to trillions of tiny living things, especially in our gut, which we call the microbiome. These gut microbes play a huge role in keeping us healthy, helping with digestion and protecting us from harmful bugs. As we get older, these gut microbes can change, and scientists believe these changes might affect our overall health, including our brain.

This study, based in East Anglia, wants to understand this connection better. Researchers will follow 360 healthy people aged 60 and over for about four years. They will look closely at how the gut microbiome changes over time and if these changes are linked to our memory and thinking skills. Learning more about this link, sometimes called the 'gut-brain axis,' could help us find new ways to improve health and wellbeing as we age and potentially prevent conditions like dementia.

The study will sort participants into three groups based on their risk of developing memory or thinking problems. This will help researchers see if there are specific gut microbe changes associated with different risk levels. The goal is to provide valuable insights that could lead to new treatments or strategies to keep our brains healthy throughout life.

Key takeaways

This study investigates the link between gut microbes and brain health in people over 60.
It aims to understand how gut changes affect memory and thinking as we age.
Participation involves regular visits, samples (stool, blood), and assessments over four years.
The study doesn't involve any new medication.
Results could help develop new strategies to keep brains healthy longer.
You need to be generally healthy and over 60 to consider taking part.

Who may be eligible?

This study is looking for healthy people aged 60 and over. You need to be able to understand information and give your consent to take part. You should also be comfortable using a tablet or iPad for some of the tests.

There are certain health conditions and circumstances that would mean you can't join the study. For example, if you've already been diagnosed with dementia or certain mental health conditions like bipolar disorder or untreated depression, you wouldn't be able to participate. Also, if you've had a stroke, epilepsy, or major gut surgery recently, or have certain gut or liver problems that need ongoing treatment, you wouldn't be suitable.

To ensure the results are clear, the study also can't include people who are taking part in another clinical study, live with or are related to the research team, or have recently made big changes to their diet. Regular use of laxatives or a history of drug or alcohol abuse would also exclude you. The aim is to study healthy ageing, so participants need to be generally well.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 60 years old or older?
Can you comfortably use a tablet or iPad?
Do you currently live in East Anglia?
Do you have a diagnosis of dementia, Parkinson's, Alzheimer's, or certain mental health conditions (like untreated depression or bipolar disorder)?
Have you had a stroke, epilepsy, or major gut surgery recently (in the last 5 years)?
Do you have ongoing gut or liver problems that need regular medical management?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be involved for about four years. After an initial phone call and a quick visit, you'll need to visit the Quadram Institute Clinical Research Facility in Norwich every six months during this period. At each visit, you will bring a stool sample (which you collect at home). At different times during the study, you'll also provide a blood sample, have various body measurements taken, and complete some memory and thinking tests and health questionnaires.

Some participants will have additional procedures. If you're part of one specific subgroup, you might have tiny tissue samples (biopsies) taken from your bowel as part of routine NHS bowel checks. Another subgroup of participants will have brain scans at the Norfolk & Norwich University Hospital. All participants will also have eye scans called Optical Coherence Tomography at Beccles & District War Memorial Hospital. The study does not involve taking any new medications.

Potential risks and benefits

Taking part in this study won't directly improve your health during the study itself, but the information gained will be very important for future research into healthy ageing and dementia. There are minimal risks involved, mostly related to giving blood samples and discomfort from procedures like bowel biopsies (if you're in that subgroup) or providing stool samples. All procedures are carried out by trained professionals. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Quadram Institute Bioscience
Verified postcode
Norwich, United Kingdom

Common questions

What is the 'microbiome' you are talking about?

The microbiome refers to all the tiny living things, like bacteria, that live inside our gut and are very important for our health.

What does 'cognition' mean?

Cognition refers to our mental abilities, including memory, thinking, problem-solving, and attention.

How long will I be in the study?

The study will last for about four years, with visits every six months.

Do I have to take any new medicines?

No, this study does not involve taking any new medications.

Where does the study take place?

The main visits will be at the Quadram Institute Clinical Research Facility in Norwich, with other scans at Beccles Hospital and potentially brain scans at Norfolk & Norwich University Hospital.