Not yet recruitingNAINTERVENTIONAL

A Real-world Study of Gastrointestinal Health and Mental Wellness in U.S. Adults Following 12 Weeks of Probiotic Supplementation.

This study, called a 'real-world' study, aims to understand how a daily probiotic supplement affects people's digestion and general wellbeing. Probiotics are often called 'good bacteria' and are found in things like yoghurt. For 12 weeks, around 300 adults in the UK who have regular stomach or bowel problems will take a probiotic. The study will track changes in their digestive symptoms, as well as how they feel mentally, how well they sleep, and their eating habits. It's looking to see if taking a probiotic can make a difference to these aspects of health.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Novonesis

Enrolment target

300

Start

01 Jan 2027

Estimated completion

01 Jun 2027

Healthy Adults Reporting Recurrent Gastrointestinal Symptoms

What is this study about?

This research is looking into how taking a daily probiotic supplement might affect your digestive health and overall wellbeing. Many people experience common stomach and bowel problems, and sometimes these can also impact how you feel day-to-day, your mood, sleep, and even eating habits. Probiotics are often called 'good bacteria' and are found in certain foods and supplements, believed to help balance the natural bacteria in your gut.

This is a 'real-world' study, which means it aims to observe what happens when people use a probiotic in their everyday lives, rather than in a highly controlled lab setting. Around 300 adults across the UK will take a probiotic supplement for 12 weeks. The main goal is to see if and how their digestive symptoms improve, and if there are any changes in their mood, sleep, or eating patterns during this time.

The findings from this study could help us better understand the link between our gut health and our overall mental and physical wellbeing. It’s important to remember that this study isn't testing a new medicine but observing the effects of a widely available dietary supplement.

Key takeaways

Study examines probiotics for gut health and wellbeing.
Looks at real-world effects over 12 weeks in adults with digestive issues.
Involves daily probiotic, smartphone app, and some saliva samples.
Not suitable for pregnant women or those with serious gut conditions.
Participation is entirely remote, no clinic visits needed.
Findings could help understand the gut-brain connection.

Who may be eligible?

To join this study, you need to be an adult aged 18 or over. You should also be someone who experiences mild-to-moderate tummy problems on a regular basis. This usually means you have tummy pain or discomfort at least three days a month, which is connected to your bowel movements, and your bowel habits (like how often you go or the type of stool) have changed. These symptoms should have been happening for at least six months.

You'll also need to have your own smartphone (either an Apple or Android device) that only you use, and you'll need to be willing to download a free study app called Trialflare. Finally, you must be prepared to take the probiotic supplement every day and provide some saliva samples and complete digital questionnaires as part of the study.

There are some reasons why you might not be able to join. For example, if you are pregnant, breastfeeding, or planning to become pregnant during the study. You also can't take part if you have a known allergy to any part of the probiotic supplement. Certain more serious health conditions, such as coeliac disease, inflammatory bowel disease (like Crohn's or ulcerative colitis), or if you've had part of your bowel removed, would also mean you can't participate. If you have severe neurological or mental health conditions, this study may not be suitable for you.

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 18 years old or older?
Do you have regular tummy pain or discomfort at least 3 days a month, connected to your bowel movements?
Have your digestive symptoms been happening for at least 6 months?
Do you own a smartphone (Apple or Android) that only you use and can download apps?
Are you *not* pregnant, breastfeeding, or planning a pregnancy during the next 12 weeks?
Do you *not* have serious gut conditions like Crohn's, ulcerative colitis, or coeliac disease?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to take a probiotic dietary supplement every day for 12 weeks. You won't need to visit a clinic; everything will be managed digitally through a smartphone app that you'll need to download.

Throughout the study, you'll use this app to answer questions about your digestive symptoms, mood, sleep, and eating habits. You'll also be asked to collect a small saliva sample at the beginning of the study and again at week 4. All instructions for collecting samples and completing questionnaires will be provided through the app. The total duration of your active participation in the study will be 12 weeks.

Potential risks and benefits

Taking part in this study could potentially help improve your understanding of how a probiotic might affect your digestive health and general wellbeing. While probiotics are generally considered safe, some people might experience mild tummy upsets like bloating or gas when first starting them. Any known allergies to ingredients in the probiotic would exclude you from the study to prevent risks. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Comet Clinical
Verified postcode
Cardiff, United Kingdom

Common questions

What exactly is a probiotic?

A probiotic is a type of 'good bacteria' that can be found in some foods and supplements. It's thought to help keep a healthy balance of bacteria in your gut, which is important for digestion.

Will I know if I'm taking the actual probiotic or a dummy pill?

This study is looking at people who *choose* to take a probiotic supplement. So, you will be taking a probiotic, not a dummy pill (placebo).

How long will I need to be involved in the study?

You'll be asked to take the probiotic every day for 12 weeks and answer questions and provide samples during this time.

Do I have to go to a clinic for appointments?

No, this study is done remotely. All your participation, including answering questions and providing samples, will be managed through a smartphone app at home.

What happens if I stop feeling well during the study?

If you feel unwell or have any concerns, you should always speak to your own doctor. You are free to leave the study at any time without giving a reason.

How to find out more

Contract Research Organisation: Comet Clinical

studygbr@cometclinical.com +1 888 493 8023 Official trial record

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