Not yet recruitingNAINTERVENTIONAL

Early Probiotic Research: Open-label Functional Intervention and Longitudinal Evaluation in Healthy Adults

This research is looking into a probiotic supplement to see if it causes any changes in healthy adults aged 50 and over. It's a small, early study to understand if the supplement is well-tolerated and if we can measure any changes in the body. Participants take one capsule daily for a month. They provide blood and stool samples at home and complete online puzzles and questionnaires about their mood and sleep. This helps us explore how the supplement might affect gut bacteria and other body markers. We are not using experimental drugs, and it's not meant to diagnose or treat illnesses, just to gather information for future research.

At a glance

Status

Not yet recruiting

Phase

Sponsor

OneCarbon

Enrolment target

Start

01 Jan 2027

Estimated completion

01 Sep 2027

Probiotic Intervention Healthy Adult Participants

What is this study about?

This research is an early study looking at a specific type of probiotic supplement. Probiotics are live bacteria and yeasts that are good for you, especially your digestive system. We want to see if taking this particular supplement, called 1C-01, for one month can make any noticeable changes in healthy adults aged 50 and over. It's important to know this is a 'pilot' study, meaning it's a small-scale trial to help us understand if it's possible to measure these changes and if the supplement is safe and well-received.

The main goal is to find out if the supplement causes any measurable changes in your body, like in your gut bacteria or other markers in your blood, and if it affects how you feel overall. We'll also be checking to make sure it's easy for people to take and doesn't cause any problems. This is not a study about new medicines; the supplement is a food-grade product, and it's being studied for research purposes only – it won't be used to diagnose, treat, or prevent any illness.

Participants will take one capsule every day for a month. During this time, they'll be asked to provide some samples and complete some online tasks. We hope the information gathered will help us learn more about probiotics and their potential effects for future, larger studies.

Key takeaways

This is an early study on a probiotic supplement (1C-01) for healthy adults.
Participants take one capsule daily for 28 days.
It involves home visits for blood and stool samples, and online tasks/questionnaires.
The study aims to see if the supplement is well-tolerated and causes measurable body changes.
It's for research only, not to diagnose or treat illness.
You must be 50 or older and not have recently taken strong antibiotics or immune-suppressing drugs.

Who may be eligible?

To join this study, you need to be a healthy adult aged 50 or older. You should be able to understand instructions in English and have access to the internet and a device like a smartphone or computer to complete online tasks. We also need you to be able to take a capsule every day and collect your own stool samples.

You can take part even if you have stable, long-term health conditions, as long as they don't affect your mind or nervous system and won't interfere with the study. However, you can't have had certain medications recently, specifically strong antibiotics within the last 8 weeks or medicines that suppress your immune system within the last 16 weeks. This is because these medicines can strongly affect your gut bacteria, which is what we're studying.

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 50 years old or older?
Do you have regular internet access and a suitable device (e.g., smartphone, computer)?
Are you able to take a capsule every day for a month and collect a stool sample yourself?
Have you avoided strong antibiotics in the last 8 weeks?
Have you avoided medicines that suppress your immune system in the last 16 weeks?
Are you generally healthy, or do you have stable, long-term health issues that don't affect your mind?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be asked to take one probiotic capsule every day for 28 days (about one month). Trained staff will visit your home twice: once at the start and once at the end of the month. During these visits, they will take a small blood sample from your arm. You will also be given a kit to collect your own stool (poo) sample at home at these same times, and the study staff will collect it from you.

Throughout the study, you'll complete online tasks and questionnaires. These include simple puzzles to check your thinking skills, and questions about your sleep, mood, and stress levels. You'll do these online tasks at the beginning and then every two weeks, lasting about an hour each time. There will also be a final questionnaire at the very end. The total time you'll be involved in the study is just over one month.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information we gather could help us learn more about probiotics and gut health for everyone. The risks involved are generally small, such as discomfort or a bruise from the blood test, and the mild inconvenience of collecting samples and completing online tasks. Probiotics are usually well-tolerated, but as with any supplement, there's always a small chance of mild side effects like an upset stomach. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

OneCarbon
Verified postcode
Cambridge, United Kingdom

Common questions

What is a probiotic?

Probiotics are live bacteria and yeasts that are thought to be good for your health, especially your digestive system. You can find them in fermented foods like yoghurt or in supplements.

Will I know if the supplement is working?

This is a research study to gather information; you won't receive individual results or advice on your health. The supplement is not for diagnosing or treating any condition.

Do I need to change my diet?

No, you don't need to change your usual diet. You also don't need to stop any current medications, as long as they aren't the specific antibiotics or immunosuppressants mentioned in the eligibility criteria.

How long will I be in the study?

You will take the supplement for 28 days (one month), and your total involvement, including initial checks and final assessments, will be just over one month.

What happens to my samples?

Your blood and stool samples will be analysed to look for changes in gut bacteria and other biological markers. They are handled carefully and kept secure for research purposes only.

How to find out more

Yizhou Yu, PhD

yizhou@onecarbon.com +44 7757 056785 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.