Not yet recruitingNAINTERVENTIONAL

Exploring Wellbeing Outcomes in Adolescents Using Bifidobacterium Longum, 1714™: a Prospective Open-Label Real-World Study

This study is exploring how a specific type of beneficial gut bacteria, called Bifidobacterium longum, 1714™, might improve well-being in teenagers aged 15-17. We know that feeling anxious, stressed, or having trouble sleeping can be common during these years. While this specific bacteria has shown promise in adults for improving stress, sleep, and overall mood, we don't have much information about its effects on teenagers yet. This study will involve teenagers who report mild-to-moderate feelings of anxiety. They will take a daily supplement containing Bifidobacterium longum, 1714™ for 8 weeks. We'll be looking at changes in their anxiety levels, sleep quality, how tired they feel, their thinking skills, and other aspects of their general well-being. The study aims to understand these effects under normal, everyday conditions in the UK.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Novonesis

Enrolment target

150

Start

01 Sep 2026

Estimated completion

01 Apr 2027

Healthy Young Adults

What is this study about?

This study is focused on understanding how a specific type of beneficial bacteria, called Bifidobacterium longum, 1714™, might affect the overall well-being of young people aged 15 to 17. We know that the teenage years can be a challenging time, and many young people experience feelings of anxiety, stress, or have difficulty sleeping. There's growing interest in how the bacteria in our gut might influence our mood and thinking, often referred to as the 'gut-brain connection'.

Previous research in adults has suggested that Bifidobacterium longum, 1714™ could help with stress, improve sleep, boost overall mood, and even help with some aspects of how we think. However, we don't have much information about how it affects teenagers. This study aims to fill that gap by observing teenagers in their everyday lives as they take this supplement.

The main goal is to see if taking this supplement daily for 8 weeks helps to reduce feelings of anxiety. We will also be looking at other important aspects of well-being, such as sleep quality, how tired participants feel, their ability to concentrate and think clearly, and how they feel about their relationships with others. The study is designed to be very real-world, meaning participants will take the supplement at home and provide feedback on how they're feeling.

Key takeaways

The study explores if a specific gut bacteria helps teen anxiety and well-being.
It's for 15-17 year olds with mild-to-moderate anxiety.
Participation involves taking a daily capsule for 8 weeks at home.
You'll use a smartphone app and a wearable device to track progress.
The study aims to understand effects in real-world conditions.
You can stop participating at any time.

Who may be eligible?

This study is looking for young people aged 15, 16, or 17 years old who live in the UK and are currently attending school or college. You should be able to read and understand English, and importantly, you should be experiencing mild to moderate feelings of anxiety. You'll need to have your own smartphone that can download apps, and your parent or legal guardian will also need to give their permission and live in the same household.

There are some reasons why you might not be able to join. For example, if you are pregnant, breastfeeding, or planning to become pregnant, or if you have any known allergies to the ingredients in the supplement. We also can't include people with certain serious medical or mental health conditions, such as bipolar disorder or diagnosed clinical anxiety or depression. If you're currently taking certain medications like antidepressants, anxiety-reducing drugs, antibiotics, or other supplements for mood or sleep, you might not be able to join, though there might be some flexibility depending on when you last took them.

Finally, you shouldn't be involved in another study that could affect this one, or currently receiving therapy like CBT for anxiety or low mood. The researchers also need to be confident that you'll be able to stick to the study plan and provide the necessary information.

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 aged 15, 16, or 17?
Do you live in the UK and go to school or college?
Do you feel mildly or moderately anxious sometimes?
Do you have your own smartphone?
Are you able to take a daily capsule and use an app?
Do you not have a diagnosed serious mental health condition or take certain medications for mood?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first go through a brief 'run-in' period of 2 weeks. After that, you'll take one capsule containing the Bifidobacterium longum, 1714™ supplement every day for 8 weeks. This will all be done from home – there are no clinic visits.

You'll need to use your smartphone to complete some questionnaires about how you're feeling, including your anxiety levels, sleep, and how tired you are. You'll also be asked to wear a special device (like a smartwatch) that we provide, which will help us track your sleep and stress levels. There will also be some simple tasks to check your thinking skills. Your parent or guardian will also be asked to provide some information. The total length of your participation, including the run-in, will be about 10 weeks.

Potential risks and benefits

Participating in this study might offer you the potential benefit of feeling better, especially regarding anxiety, sleep, and overall mood, if the supplement has positive effects. However, it's also possible that you won't experience any changes. As with any supplement, there's a small chance of mild side effects, or you might find wearing the device or completing the questionnaires inconvenient. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care or your relationship with your doctor. Your decision to participate or withdraw will always be respected.

Locations (1)

Comet Clinical
Verified postcode
Cardiff, United Kingdom

Common questions

What is Bifidobacterium longum, 1714™?

It's a specific type of friendly bacteria found in the gut, which is being studied for its possible benefits on mood and well-being.

Will I have to go to a clinic?

No, this study is done remotely from your home. You'll use your smartphone and a wearable device.

How long will I take the supplement?

You will take one capsule daily for 8 weeks, after a 2-week preparation period.

What if I feel worse during the study?

You can stop taking the supplement and withdraw from the study at any time. You should always discuss any health concerns with your doctor.

Will my parents know everything I say?

Your parents will provide consent for you to join, and some information, but your individual answers to surveys are kept private and anonymous where possible.

How to find out more

Charlotte Chadwick

studyzt@cometclinical.com +44 (0)2921 203279 Official trial record

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