Active not recruitingPHASE2INTERVENTIONAL

MARVEL: Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis

The MARVEL study is exploring a new treatment called MitoQ for people experiencing a flare-up of ulcerative colitis (UC). UC is a condition where the lining of the large bowel becomes inflamed and develops sores, leading to symptoms like bloody diarrhoea and extreme tiredness. Existing treatments can be strong and have side effects. Researchers believe MitoQ could offer a gentler, more targeted approach. This 24-week study will give either MitoQ or a placebo (dummy pill) daily to patients who are also starting standard steroid treatment. The aim is to see if MitoQ helps symptoms and gut inflammation improve more effectively, and if it reduces the need for stronger medications.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

University of Edinburgh

Enrolment target

Start

31 May 2022

Estimated completion

30 Nov 2026

Ulcerative Colitis Flare

What is this study about?

Ulcerative colitis (UC) is a long-term condition that affects your large bowel (colon and rectum). It causes inflammation and sores (ulcers) on the inside lining. This can lead to symptoms like stomach pain, urgent need to go to the toilet, bloody diarrhoea, and severe tiredness. Sometimes, if the inflammation is very bad, it can be quite serious and might even need emergency surgery.

Our bodies have tiny 'power stations' called mitochondria inside our cells, which give them energy. In people with UC, these mitochondria in the gut lining can get damaged. When this happens, they send out 'danger signals' that attract immune cells, making the inflammation worse. The MARVEL study is looking into whether a drug called MitoQ can protect these mitochondria. By doing so, we hope it might reduce the danger signals and calm the inflammation in the gut, helping it to heal better during a flare-up.

MitoQ has been tested in other health conditions and found to be safe. We believe it could be a different type of treatment for UC. Many current UC medicines are very strong and work by dampening down the whole immune system. MitoQ, on the other hand, aims to target and block the specific signal that causes inflammation in the gut. If this study shows MitoQ is helpful, it could offer a safer and potentially more affordable new option for people with UC.

Key takeaways

The MARVEL study is testing a new drug, MitoQ, for ulcerative colitis flare-ups.
MitoQ aims to protect cell 'power stations' (mitochondria) to reduce gut inflammation.
It's a 24-week study where participants take MitoQ or a dummy pill daily, alongside starting steroids.
The goal is to see if MitoQ can improve symptoms and gut healing more effectively.
If successful, MitoQ could offer a new, potentially safer treatment by targeting inflammation specifically.
Regular assessments at 12 and 24 weeks will check progress and how you are feeling.

Who may be eligible?

To join this study, you would need to be 18 years or older and have a confirmed diagnosis of ulcerative colitis for at least three months. Importantly, you must be experiencing a flare-up of your UC right now, severe enough that your doctor has decided you need to start a steroid medication called prednisolone. You'd be able to join even if you're already on other common UC medications like 5-ASA or a low dose of azathioprine, as long as you've been on a steady dose for a while.

However, this study might not be suitable for everyone. For example, if your UC flare is extremely severe, or if you've recently had very serious complications like a hole in your bowel, you wouldn't be able to take part. Also, if you've previously been treated with certain strong biologic drugs or other specific UC medications, or if your UC only affects a very small part of your rectum, you wouldn't be eligible. The study also cannot include pregnant or breastfeeding individuals, or those with another bowel condition called Crohn's disease.

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 a confirmed diagnosis of ulcerative colitis?
Are you currently experiencing an ulcerative colitis flare-up, requiring new steroids (prednisolone)?
Have you *not* had very severe UC complications recently (like a hole in your bowel)?
Are you *not* pregnant or breastfeeding, and not planning to become pregnant during the study?
Have you *not* previously used certain strong biologic medications for your UC?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the MARVEL study, you would be randomly assigned to receive either the study drug, MitoQ, or a placebo (a dummy pill that looks exactly like MitoQ but contains no active drug). You would take one capsule every day for 24 weeks. During this time, you would also be starting a standard course of oral prednisolone, a steroid medication for your UC flare, as decided by your doctor.

You would have assessments at different points during the 24 weeks – specifically after 12 weeks and again at 24 weeks. These assessments will help the study doctors understand how well the treatment is working. They will check your symptoms, and may involve tests to look at the inflammation in your gut. These visits are important for monitoring your health and the progress of your UC. The total duration of the active treatment phase in the study is 24 weeks.

Potential risks and benefits

By taking part in this study, you might benefit from a new treatment for your ulcerative colitis. There's a chance MitoQ could help improve your symptoms and gut healing more effectively than standard care alone, and potentially reduce your need for stronger medications. However, as with any study, there are potential risks. The most common side effects of MitoQ have been mild in other studies, but any new medication can have unexpected effects. As you will also be taking prednisolone, you would experience any side effects associated with that medication. You will be closely monitored by the study team, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

NHS Lothian
Verified postcode
Edinburgh, United Kingdom

Common questions

What is the main goal of the MARVEL study?

The main goal is to see if MitoQ can help reduce inflammation and improve symptoms in people having an ulcerative colitis flare, potentially offering a new treatment option.

What exactly is MitoQ?

MitoQ is a drug being tested that aims to protect the 'power stations' (mitochondria) inside your gut cells, which we believe could help calm inflammation in ulcerative colitis.

Will I know if I'm getting MitoQ or a placebo?

No, this is a 'blinded' study, meaning neither you nor your study doctor will know if you're receiving MitoQ or the placebo. This helps make the study results as fair and accurate as possible.

How long will I be taking the study medication?

You will be taking either MitoQ or the placebo as a capsule once a day for 24 weeks (about 6 months).

Can I continue my current UC medications if I join?

Yes, in many cases, you can continue certain stable UC medications like 5-ASA or azathioprine. The study team will review your specific medications to confirm.