CompletedObservational

Exploring biomarkers of mucosal inflammation in paediatric Crohn’s disease (Mini-MUSIC)

The Mini-MUSIC study is for children and young people aged 6-17 in Scotland who have Inflammatory Bowel Disease (IBD), including Crohn's disease and ulcerative colitis. Researchers want to find better ways to understand and measure inflammation in the gut without relying as much on uncomfortable procedures like endoscopies, which involve general anaesthesia for children. They will collect blood, stool, and saliva samples over a year, along with some extra tissue samples if you're already having an endoscopy. The goal is to discover new biological signals (called 'biomarkers') that can tell doctors how inflamed the gut lining is. This could lead to simpler, less invasive ways to monitor IBD in the future.

At a glance

Status

Completed

Sponsor

Accord (United Kingdom)

Enrolment target

120

Start

01 Jan 2024

Estimated completion

31 Dec 2025

Paediatric inflammatory bowel disease

What is this study about?

Imagine your body has a special way of showing when something isn't quite right, like a 'check engine' light in a car. In this study, called Mini-MUSIC, doctors are looking for these special signals, or 'biomarkers,' in children and young people with Inflammatory Bowel Disease (IBD). IBD includes conditions like Crohn's disease and ulcerative colitis, where the gut lining becomes inflamed.

Currently, to see how inflamed the gut is, doctors often need to perform an endoscopy. This is a procedure where a tiny camera is used to look inside the gut, and for children, it means having a general anaesthetic. It can be uncomfortable and uses up NHS resources. The researchers believe there might be simpler ways to check gut health, perhaps through things like blood or stool tests.

This study hopes to find a panel of new biomarkers – measurable signs in your blood, stool, and even saliva – that can accurately show how much inflammation is present or how well the gut lining has healed. They'll compare these new tests with what doctors see during endoscopies. By doing this, they hope to develop better, less invasive ways to monitor IBD in children, giving both patients and doctors a clearer picture of what's happening inside.

Key takeaways

A study for children and young people (6-17) with active IBD in Scotland.
Aims to find new, less invasive ways to monitor gut inflammation.
Involves three visits over one year for assessments and sample collection (blood, stool, saliva).
No new medications are given; you continue your standard NHS treatment.
Your participation helps improve understanding of IBD for future patients.
Risks are minimal, mainly discomfort from blood tests.

Who may be eligible?

This study is looking for children and young people living in Scotland who are between 6 and 17 years old and have been diagnosed with Inflammatory Bowel Disease (IBD). This includes Crohn's disease, ulcerative colitis, or IBD-unclassified.

For you to be considered, your IBD must be active when you join the study. Your doctor will decide if your IBD is active based on your symptoms and some test results, like a stool test (faecal calprotectin) or blood test (CRP). In some cases, previous endoscopy results will also be looked at.

Even if you've recently had an endoscopy, you might still be able to join. If you're switching IBD treatments because your current one isn't working, or if you're having an active flare-up, you could also be suitable for the study.

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 6 and 17 years old?
Do you live in Scotland?
Have you been diagnosed with Crohn's disease, ulcerative colitis, or IBD-unclassified?
Is your IBD currently active, based on your symptoms or recent tests?
Are you able to attend three study visits over one year?

Answer every question to see your result.

What does participation involve?

If you take part in the Mini-MUSIC study, you'll be followed regularly over one year. This will involve three visits in total. At each visit, a doctor or nurse will check how you're feeling and conduct a detailed health assessment. You'll also be asked to provide some samples, including blood, a stool (poo) sample, and a saliva (spit) sample.

If you are already scheduled to have an endoscopy as part of your usual care from the NHS, the study team may ask to take some extra, very small tissue samples (biopsies) during that procedure. This won't involve any additional endoscopies just for the study. The study looks at how your body responds to the standard treatments you're already receiving from your NHS consultant, so you won't be given any new or experimental medications as part of the study.

Potential risks and benefits

There isn't a direct personal benefit to you from taking part in this study, but your contribution will be very valuable in helping doctors and researchers learn more about IBD in children and young people. This could lead to better ways of managing the condition for future patients. The main risks are very small; they mostly relate to discomfort from having blood samples taken, such as a brief sting or bruise. If extra tissue samples are taken during an endoscopy you're already having, current understanding is that this doesn't add any extra risk. Remember, you can decide to stop being part of the study at any time without it affecting your medical care.

Locations (4)

Royal Hospital for Children, Glasgow
Approximate
Glasgow, United Kingdom
Royal Hospital for Children and Young People
City only
Lothian, United Kingdom
Royal Aberdeen Children's Hospital
Approximate
Aberdeen, United Kingdom
Tayside Children's Hospital
City only
Dundee, United Kingdom

Common questions

What is IBD?

IBD stands for Inflammatory Bowel Disease, which causes long-lasting inflammation in the digestive system. Crohn's disease and ulcerative colitis are the main types.

What is an endoscopy?

An endoscopy is a medical procedure where a thin, flexible tube with a camera is used to look inside the body, often the digestive system, to check for problems.

What are 'biomarkers'?

Biomarkers are like natural signals or clues in your body (like in blood or stool) that can tell doctors about your health, including if there's inflammation.

Will I get new medicines in this study?

No, you will continue to receive the standard treatments your NHS doctor has prescribed. This study simply observes how you respond to your current care.

Can I stop participating if I change my mind?

Yes, you are free to withdraw from the study at any time without your medical care being affected.

How to find out more

David Wands

dwands@ed.ac.uk +44 (0)7951491946 Official trial record

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