RecruitingOBSERVATIONAL

Mitochondrial DAMPs as Mechanistic Biomarkers of Mucosal Inflammation in Crohn's Disease and Ulcerative Colitis

The MUSIC study aims to find new, easier ways to understand how inflamed your gut is if you have Crohn's disease or ulcerative colitis. Currently, doctors often use a camera test (like a colonoscopy) to see the gut lining directly, but this can be uncomfortable and isn't always practical. This study is exploring a new approach that looks at special signals, called 'danger signals', in your blood, poo, and gut samples. These signals are released when your body's cells are stressed or injured. By studying these signals, we hope to develop a simple blood or poo test that can accurately show whether your gut lining is healing well with treatment. This could help both patients and doctors make better decisions about treatment.

At a glance

Status

Recruiting

Sponsor

University of Edinburgh

Enrolment target

250

Start

27 Jan 2021

Estimated completion

31 Dec 2025

Inflammatory Bowel Diseases

What is this study about?

The MUSIC study is looking for better ways to understand how active Crohn's disease and ulcerative colitis (types of Inflammatory Bowel Disease or IBD) are in your gut. For people with IBD, the main goal of treatment is to heal the gut lining completely, as this often leads to a better long-term outlook. Currently, doctors mainly rely on your symptoms (like how you feel and if you have blood in your poo), and some blood and poo tests to see if treatment is working. However, these methods don't always give a full picture. For example, some people feel better, but a camera test shows their gut is still inflamed.

The best way to know if your gut is healing is through a camera test (like a colonoscopy or sigmoidoscopy), which lets doctors see the gut lining directly. While these tests are very accurate, they are invasive, can be uncomfortable, and aren't easy to do regularly in the NHS. This means doctors sometimes don't know exactly how well your gut is responding to treatment, which can make it harder to decide if your medicine needs to be changed.

This study is focusing on something called 'danger signals'. These are released by your own cells when they're stressed or injured, and they can cause inflammation. We will collect samples of blood, poo, and gut tissue from patients taking part, both when their IBD is active and when it's in remission (a period where symptoms are reduced or gone). By examining these danger signals in the samples, we hope to find a new, simpler test that accurately shows how inflamed your gut is and whether it's healing, without needing frequent camera tests. This could lead to more personalised treatment plans.

Key takeaways

Aims to find easier ways to check IBD gut inflammation.
Compares new blood/poo tests to traditional camera tests.
Focuses on natural 'danger signals' from cells.
Could help doctors tailor IBD treatment more effectively in the future.
Involves regular check-ups and samples over one year.

Who may be eligible?

To take part in the MUSIC study, you must be at least 16 years old and have a confirmed diagnosis of Crohn's disease or ulcerative colitis. At the time you join, your IBD needs to be active. This means your doctor thinks your symptoms are flaring, and you'll also meet specific criteria based on blood or poo tests, or a recent camera test showing inflammation.

We need to be able to check your gut lining with a camera test (like a colonoscopy or sigmoidoscopy) as part of the study, so your IBD must affect parts of your bowel that can be easily seen this way. If you've had a recent camera test showing active IBD, or are willing to have one when you join, you might be eligible.

However, if your IBD symptoms are very severe and you are considered to have "fulminant" (very rapid and intense) disease, you won't be able to participate. This study is designed for patients with active IBD who are not in this extremely severe category.

Quick self-check

Are you 16 years old or older?
Do you have a confirmed diagnosis of Crohn's disease or ulcerative colitis?
Is your IBD currently active, based on your doctor's assessment and recent tests?
Can your IBD be assessed by a camera test (like a colonoscopy)?
Are you willing to have samples (blood, poo, gut) taken during the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in the MUSIC study, you'll be followed for one year while you receive treatment for your IBD from your NHS doctor. During this time, you will have several study visits. At these visits, we will collect samples of your blood, poo, saliva, and small gut samples (biopsies). Some of these will be taken at the same time as your usual camera tests for IBD.

You will also have regular camera tests, such as an ileo-colonoscopy or flexible sigmoidoscopy, to allow doctors to directly see the state of your gut lining. This is a crucial part of the study as it provides the 'gold standard' for comparison against the new markers we are testing. The study collects information on how your disease progresses and how it responds to the treatments your own IBD consultant prescribes.

Potential risks and benefits

Taking part in this study won't directly improve your current IBD treatment, as you'll be receiving the standard care from your doctor. However, your involvement could help future patients by leading to better, less invasive ways to monitor IBD. The main potential risks are those associated with routine blood tests and endoscopies, such as minor bruising or discomfort, which will be explained in detail. You are free to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (3)

Ninewells Hospital
Dundee, United Kingdom· Not yet recruiting
Western General Hospital
Edinburgh, United Kingdom· Recruiting
NHS Greater Glasgow & Clyde
Glasgow, United Kingdom· Not yet recruiting

Common questions

What are "danger signals"?

Danger signals are natural alarms released by your own cells when they are stressed or damaged. They can trigger inflammation, and we're studying how they work in IBD.

Will I get new medicine in this study?

No, you will keep receiving the standard IBD treatment that your NHS doctor would normally prescribe for you.

Do I need to have a camera test (colonoscopy) if I join?

Yes, having specific camera tests is an important part of the study to help us compare new tests with the best current way of checking your gut.

How long will I be in the study?

You will be followed for one year as part of the MUSIC study.

Will this study help me feel better?

The study itself won't change your current treatment or directly make you feel better, but it aims to find better ways to help future IBD patients.

How to find out more

Gwo-Tzer Ho

G.Ho@ed.ac.uk 01312426653 Official trial record

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