CompletedInterventional

A pilot study investigating a probiotic strain for health and well-being

This study wants to see if a specific probiotic, a good gut bacteria called Levilactobacillus brevis, can help improve blood sugar levels and overall health. If you're a man aged 25-50 or a woman aged 25-45 with slightly high blood sugar, you might be able to take part. You'll take either a high dose, low dose, or dummy pill (placebo) once a day for 6 weeks. The study involves wearing a blood sugar monitor, giving a few samples (blood and poo), and filling in online questionnaires. It’s all done remotely from your home, coordinated by Lindus Health in the UK. The aim is to understand if this probiotic can help manage blood sugar.

At a glance

Status

Completed

Sponsor

Danisco Sweeteners Oy, a wholly owned subsidiary of International Flavors & Fragrances Inc. (IFF)

Enrolment target

Start

23 May 2025

Estimated completion

02 Feb 2026

Individuals with HbA1c levels between 39.0 mmol/mol and 51.9 mmol/mol (5.7% to 6.9%)

What is this study about?

This study, called "A pilot study investigating a probiotic strain for health and well-being," is exploring a new way to help manage blood sugar levels. Scientists are curious if a special type of good bacteria, known as a probiotic, can make a difference. The specific probiotic they are testing is called Levilactobacillus brevis.

You might be interested if you have blood sugar levels that are a little higher than normal but not yet at the level for a diagnosis of diabetes. This is often an early warning sign. The study aims to see if taking this probiotic might help gently bring these sugar levels down and improve your overall metabolic health. They'll compare different strengths of the probiotic against a 'dummy' pill (called a placebo) to see if it really works.

It's important to remember that this is a pilot study, meaning it's one of the first steps in understanding this probiotic. It's a way to gather important information that could lead to bigger studies in the future if the results are promising. The study is run by Lindus Health in the UK, and you can take part from the comfort of your own home.

Key takeaways

This study is testing a probiotic for blood sugar control.
It's for people with slightly high blood sugar (pre-diabetes range).
Participation is remote from home for 10 weeks.
You'll take a daily supplement, wear a monitor, and provide small samples.
Potential benefits include health information; risks are generally minor.

Who may be eligible?

This study is looking for volunteers who are generally healthy but have blood sugar levels that are a bit higher than ideal, falling between 5.7% and 6.9% on a blood test called HbA1c. This level often means you're at an increased risk of developing type 2 diabetes.

To join, you need to be a man aged between 25 and 50, or a woman aged between 25 and 45 who hasn't gone through menopause. Your body mass index (BMI) should also be between 20 and 45. It's important that your weight has been stable over the last year, without big changes.

You cannot be currently taking any medication for diabetes or using special dietary supplements that might affect your blood sugar. You also need to be willing to keep your usual diet and exercise habits throughout the study, without making big changes, and be happy to wear a small device that monitors your blood sugar.

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 a man aged 25-50 or a non-menopausal woman aged 25-45?
Do you have an HbA1c blood sugar level between 5.7% and 6.9%?
Is your weight generally stable, and is your BMI between 20-45?
Are you not taking diabetes medication or other special blood sugar supplements?
Are you willing to wear a blood sugar monitor and keep your usual lifestyle?
Do you have access to a smartphone, tablet, or computer?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly put into one of three groups, a bit like drawing names from a hat. You'll either receive a high dose of the probiotic, a low dose of the probiotic, or a dummy pill (placebo). You won't know which one you're taking, and neither will the study team – this helps make the results fair.

You'll take your assigned pill once a day for 6 weeks. Throughout the study, which lasts for 10 weeks in total, you'll be asked to wear a continuous glucose monitor (CGM) for certain periods. This is a small sensor you wear that checks your blood sugar levels automatically. You'll also need to provide a few blood samples and stool (poo) samples, and complete online questionnaires about things like what you eat, how active you are, how well you sleep, and your overall quality of life. The good news is that most of this can be done from your home.

Potential risks and benefits

Taking part in this study could offer some benefits, such as receiving information about your own blood sugar levels and how your body processes sugar. There's also a chance the probiotic might help improve your blood sugar control. Any risks involved are considered very small. You might experience some temporary tummy discomfort like bloating or gas from the probiotic. Applying the glucose monitor might cause minor discomfort, and blood tests can sometimes lead to a little pain or bruising. Remember, you have the right 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.

Lindus Health
City only
London, England

Common questions

What is a probiotic?

A probiotic is a type of 'good' bacteria that can live in your gut and may offer health benefits, often found in foods like yogurt or supplements.

What does 'HbA1c' mean?

HbA1c is a blood test that shows your average blood sugar levels over the past 2-3 months. It's used to check for diabetes or pre-diabetes.

Will I have to go to a clinic?

No, this study is designed for remote participation. You can take part from your home in the UK.

What is a 'placebo'?

A placebo is a 'dummy' pill or treatment that looks the same as the real one but contains no active ingredient. It helps researchers see if the real treatment actually works.

Who is paying for this study?

The study is funded by Danisco Sweeteners Oy, which is part of a company called International Flavors & Fragrances Inc. (IFF).

How to find out more

Beth Hawkins

beth@lindushealth.com +44 (0)800 0584496 Official trial record

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