Active not recruitingOBSERVATIONAL

Multi-centre Acute Severe Ulcerative Colitis Prospective Cohort Study (Elevate ASUC)

This study is for people recently admitted to hospital with a severe flare-up of ulcerative colitis (UC). This is a type of bowel condition. We know that up to a third of people with UC will need hospital care for severe symptoms, sometimes in the first year after diagnosis. Unfortunately, about 30-40% of these patients might end up needing surgery to remove their colon. Currently, doctors don't have clear ways to predict which patients will respond well to initial treatments like steroids, or which ones might need earlier, stronger medicine or surgery to avoid major complications. This research aims to collect detailed information from many patients to better understand the best ways to manage severe UC and help doctors offer more personalised care in the future.

At a glance

Status

Active not recruiting

Sponsor

Hull University Teaching Hospitals NHS Trust

Enrolment target

189

Start

18 Oct 2019

Estimated completion

31 Aug 2026

Severe Ulcerative Colitis

What is this study about?

When you have ulcerative colitis, sometimes your symptoms can become very severe, leading to a hospital stay. This can be a very challenging time. Doctors usually start with strong medicines called intravenous steroids to try and calm down the inflammation in your bowel. However, for a significant number of people (around 4 out of 10), these steroids don't work well enough. This can lead to needing further treatment, possibly including different medicines or even surgery to remove part or all of your large bowel. This surgery, while sometimes necessary, does carry its own risks.

At the moment, doctors don't have good tools to predict early on which patients will respond to the initial steroid treatment and which ones might need more intensive treatment or surgery. This means it's hard to personalise your care from the start. This study, called Elevate ASUC, aims to gather a lot of information from many different hospitals across the country about patients who are admitted with severe ulcerative colitis. By carefully collecting details about your symptoms, test results, and how you respond to different treatments over time, researchers hope to find patterns.

The goal is to develop better ways to understand and manage severe ulcerative colitis. For example, they want to find clues that might tell doctors early on if standard treatments are unlikely to work for you. This could help doctors decide if you might benefit from stronger medicines, known as "rescue therapy," or if surgery might be a better option sooner rather than later. Ultimately, this research aims to improve care, reduce the need for emergency surgery, and help people get better more quickly and safely.

Key takeaways

The study aims to improve understanding of severe ulcerative colitis.
It collects information from patients already in hospital for a flare-up.
You will receive standard medical care, not new treatments.
Your participation helps future patients with the same condition.
Your private information will be kept confidential.
You can stop participating at any time.

Who may be eligible?

To be able to take part in this study, you would need to be between 18 and 80 years old. You must have been diagnosed with severe ulcerative colitis and currently be in hospital receiving intravenous (into the vein) steroid treatment for at least two days. You also need to be able to understand and sign the consent form yourself.

You wouldn't be able to join the study if you have Crohn's disease, or if your hospital admission is planned for a routine operation. You also can't take part if your colitis is caused by an infection, if you are pregnant, or if you've already had surgery related to your colitis, like a stoma or a pouch. Finally, if you're unable to give your own consent, you wouldn'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 18 and 80 years old?
Have you been diagnosed with severe ulcerative colitis?
Are you currently in hospital receiving IV steroids for it?
Can you understand and sign a consent form yourself?
Have you previously had a stoma or pouch surgery for colitis? (If yes, you can't join)
Is your colitis caused by an infection or are you pregnant? (If yes, you can't join)

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the doctors and nurses involved will collect information about your health. This will include details about your symptoms, the medicines you're given, results from any blood tests or stool tests, and any scopes you might have. They will also look at how your condition changes over time while you are in the hospital and after you go home. You won't be given any new or experimental treatments as part of the study; instead, all participants will receive the standard care that your doctors decide is best for you. The study mainly involves collecting existing information, so it won't add extra appointments or visits to your usual care plan. The total duration of your participation would involve collecting information throughout your hospital stay and then following up on your progress for a period afterwards.

Potential risks and benefits

Taking part in this study mainly involves sharing your medical information, so there aren't direct risks to your health from the study itself, as you'll be receiving your usual treatment. The main benefit is knowing that your information could help other people with severe ulcerative colitis in the future by improving how doctors understand and treat the condition. There are no direct personal benefits to you. Remember, joining any study is completely your choice, and you have the right to withdraw at any time without it affecting your medical care.

Locations (1)

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

Gastroenterology, Hull Royal Infirmary, Hull University Teaaching Hospitals NHS Trust
Verified postcode
Hull, United Kingdom

Common questions

What is 'standard of care'?

Standard of care means the usual treatments and medical practices that doctors currently use and recommend for your condition.

Will I have to take any new medicines?

No, this study doesn't involve giving you any new or different medicines. You will receive the standard medical care your doctors choose for you.

How long will the study follow my progress?

The study will collect information during your hospital stay and then follow up on your progress afterwards. The exact length of follow-up will be explained by the study team.

Will my personal details be kept private?

Yes, all your medical information will be kept strictly confidential. Your name will not be used in any reports or publications from the study.

Can I leave the study at any time?

Yes, you are completely free to withdraw from the study at any point without it affecting your care or relationship with your doctors.