RecruitingNAINTERVENTIONAL

Colon-delivered Riboflavin and Gut Microbiota Composition

This research trial aims to understand how different forms of vitamin B2 (riboflavin) impact the bacteria living in our gut and our general gut health. Scientists believe that B vitamins might act like prebiotics, which are substances that feed good gut bacteria. This study focuses on people aged 50 to 70 who experience mild bowel issues. It compares a new way of delivering vitamin B2 directly to the colon with standard vitamin B2 and a placebo (a dummy pill). The goal is to see if delivering the vitamin this way offers better benefits for gut microbiota and metabolic activity, potentially improving gut health more effectively than traditional methods.

At a glance

Status

Recruiting

Phase

Sponsor

dsm-firmenich Switzerland AG

Enrolment target

Start

18 Jul 2025

Estimated completion

01 Sep 2026

Microbiome Dysbiosis Gut Health

What is this study about?

You might have heard about the 'gut microbiome' – that's the community of trillions of tiny bacteria and other microbes living in your intestines. These tiny residents play a big part in your overall health, including how you digest food and even your immune system. When this community is out of balance, it can lead to various gut problems.

This study is looking into whether vitamin B2, also known as riboflavin, can help improve this balance. Some early research suggests that B vitamins could act like 'prebiotics'. Prebiotics are foods or supplements that encourage the growth of helpful gut bacteria. The interesting part of this study is that it's comparing a new way of getting vitamin B2 directly to your colon (the last part of your large intestine) with the usual way of taking vitamin B2, and also with a dummy pill (placebo).

The main aim is to see if this special colon-delivered vitamin B2 can make a noticeable difference to the types and numbers of bacteria in your gut, and how active they are. Researchers also want to find out if it generally improves gut health in people between 50 and 70 years old who have some mild bowel complaints. Understanding this could help us find new ways to support a healthy gut.

Key takeaways

This study explores a new way to deliver vitamin B2 directly to the gut.
It aims to understand how different vitamin B2 forms affect gut bacteria and overall gut health.
Participants will be aged 50-70 with mild bowel complaints.
The study compares special vitamin B2 to regular vitamin B2 and a dummy pill.
Results could help improve treatments for gut health in the future.

Who may be eligible?

To join this study, you need to be a man or a woman aged between 50 and 70 years old. If you're a woman, you must have gone through menopause, meaning you haven't had a period for at least a year. Your body mass index (BMI), which is a measure of your weight compared to your height, needs to be within a healthy range (between 18.5 and 29.9).

You should generally be in good health, as checked by the study doctor. You also need to have experienced mild bowel problems, such as indigestion, constipation, or diarrhoea, for at least the past three months. It's important that your weight has been stable for the last three months, and you must be willing to avoid certain gut-modulating supplements like probiotics or high-fibre supplements for the entire study. If you take regular medications, your dosage must remain the same throughout the study.

You cannot join if you are allergic to any part of the study products or a specific diet addition (inulin). You also can't have taken antibiotics in the last three months or be expected to take them during the study. If you've been using certain supplements that affect gut bacteria in the last four weeks, or if you regularly use certain medications like systemic steroids, you won't be able to participate.

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 between 50 and 70 years old?
If female, have you had your last period at least one year ago?
Do you have mild digestion problems, like indigestion, constipation, or diarrhoea?
Have you kept a stable weight for the past 3 months?
Are you able to avoid gut-related supplements (like probiotics) during the study?
Have you avoided antibiotics in the last 3 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be asked to give your written consent, meaning you understand and agree to participate. You'll have an initial health check-up, including answering questions, a physical exam, and checking your blood pressure and pulse.

The study involves taking a study product (either colon-delivered vitamin B2, conventional vitamin B2, or a placebo) for a set period. You'll need to maintain your usual level of physical activity and avoid certain dietary supplements that can affect your gut bugs throughout the study. You'll also be asked to maintain the same dosage for any chronic medications you're already taking. The study will involve follow-up visits or assessments to monitor your gut health, metabolic activity, and any changes in your bowel complaints. The total duration of your involvement will be clearly explained by the study team.

Potential risks and benefits

Participating in this study might offer you the potential benefit of improving your gut health and understanding more about how vitamin B2 affects your body. However, there are also potential risks, such as possible side effects from the study product, although riboflavin is generally considered safe. You might also find the study requirements, like avoiding certain supplements, restrictive. It's important to remember that as a participant, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

analyze & realize GmbH
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is 'gut microbiota'?

It's the name for all the tiny living things, like bacteria, that live in your gut and help you stay healthy.

What is riboflavin?

Riboflavin is another name for Vitamin B2, an important vitamin found in food that helps your body work properly.

What is a 'placebo'?

A placebo is a dummy pill or treatment that looks the same as the real one but contains no active ingredients. It helps researchers see if the real treatment works better than nothing.

Will I know which treatment I'm getting?

No, this is a 'blinded' study, meaning neither you nor the study team will know which treatment you are receiving until after the study is complete. This helps ensure fair results.

Why are people aged 50-70 being studied?

This age group often experiences changes in gut health, and the study wants to see if the interventions can specifically benefit them.

How to find out more

Veronika Bobb, Dr.

vbobb@a-r.com +49 30 4000 8152 Official trial record

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