RecruitingNot SpecifiedObservational

Better understanding of the causes, how best to treat and how to develop new medications for Crohn’s and colitis by studying human cells and gut microbes

This research wants to understand why Crohn's and colitis affect people differently and how best to treat them. Experts will study human cells, gut germs (like bacteria and viruses), and other factors in people newly diagnosed with these conditions over two years. By doing this, they hope to predict how the condition might progress, develop new medicines, and help patients and their doctors choose the best care. The study involves collecting samples and health information from people aged 16 and over, with or without Crohn's or colitis. It could lead to better, more personalised treatments for everyone with these conditions in the future.

At a glance

Status

Recruiting

Phase

Not Specified

Sponsor

Newcastle upon Tyne Hospitals NHS Foundation Trust

Enrolment target

2,000

Start

10 Mar 2025

Estimated completion

31 Dec 2028

Inflammatory bowel disease

What is this study about?

Crohn's disease and ulcerative colitis, often called inflammatory bowel disease (IBD), are lifelong conditions that cause inflammation in the gut. We're seeing more people diagnosed every year, but we don't fully understand why they start or why some people have very mild symptoms while others have more severe problems that are harder to treat.

This study, called Open-IBD, aims to change that. Our team wants to explore what makes each person's experience with Crohn's and colitis unique. We'll be looking closely at cells in the blood and gut, tiny germs (like bacteria, viruses, and fungi) that live in your gut, and other health information. By gathering this detailed information from people when they are first diagnosed and then over the next two years, we hope to unlock important clues.

Ultimately, we believe this research will help us in the future. It could allow doctors to predict how someone's Crohn's or colitis might behave, guide them to choose the most effective treatments much earlier, and even lead to the development of brand new medicines. Our goal is to empower patients and their healthcare teams to make truly personalised decisions about their care.

Key takeaways

Aims to understand why Crohn's and colitis affect people differently.
Hopes to predict disease progression and guide treatment choices.
Involves regular sample collection and health questionnaires over two years.
Could offer more frequent check-ups and expert access for participants.
The findings aim to benefit the wider IBD community in the long run.
You can stop participating at any time without affecting your NHS care.

Who may be eligible?

This study is looking for adults aged 16 and over who your doctor thinks might have Crohn's disease or ulcerative colitis. This usually means you've been sent to the hospital because of gut symptoms, or tests have suggested you might have a problem like inflammatory bowel disease.

You might be eligible if you're newly referred to the hospital for gut symptoms, or if scans have shown signs of inflammatory bowel disease but you haven't had a scope yet. Even if you've recently been admitted to the hospital with new gut inflammation, you could still be considered.

However, you can't join if you're already taking specific strong medications like oral steroids (unless it's been for a very short time, usually 7 days or less) or other advanced treatments for your suspected gut condition. You also need to be willing to complete questionnaires, provide stool samples at home, and allow blood and tissue samples to be taken during hospital visits.

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 16 years old or older?
Has your doctor suggested you might have Crohn's disease or ulcerative colitis?
Are you willing to give blood, stool, and tissue samples?
Are you able to complete questionnaires about your health and lifestyle?
Are you not currently taking specific strong medications like oral steroids or advanced therapies (unless for a very brief period) for your suspected condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step involves giving a stool sample and a blood sample, and filling out some questionnaires about your lifestyle, diet, and how your symptoms affect you. Our team will also take some extra tissue samples during your diagnostic colonoscopy (a procedure where doctors look inside your bowel with a camera), which you'd be having anyway as part of your standard care.

If tests show you don't have Crohn's or colitis, you won't need any more research visits. However, we might check your health records later to see if you develop any related symptoms or conditions. If you are diagnosed with Crohn's or colitis, we'll ask you to provide stool and blood samples every three months for the first year, and then every six months for the second year. You'll also complete health questionnaires at these times. About a year after your diagnosis, you'll have another colonoscopy to check how your bowel is doing.

Taking part in this study won't change the treatment you receive from your doctors. However, if you are diagnosed with Crohn's or colitis, you might have check-ups more often and have closer contact with your specialist team than if you weren't in the study. The study is expected to run from January 2024 to July 2029.

Potential risks and benefits

There are several potential benefits to taking part. You'll have regular appointments with experts who are very experienced in managing Crohn's and colitis, and you might receive a diagnosis faster than in standard NHS care. These appointments can offer extra support, knowledge, and expert advice regularly after your diagnosis. If you're diagnosed with Crohn's or colitis, the regular tests included in the study will provide detailed information about how you're responding to treatments and could help spot problems early. This includes a follow-up colonoscopy after 12 months to check your bowel's health and see if any treatment changes are needed. The main long-term benefit of this study is for the wider community of people with Crohn's and colitis, as it aims to improve our understanding, develop new treatments, and help identify those who need early, intensive treatment. Like all medical procedures, collecting blood and tissue samples carries small risks, but these are kept as low as possible by experienced healthcare staff. These sample collections are routine even if you don't join the study. Blood tests can cause a little discomfort or a small bruise. Tissue samples (biopsies) are taken during your colonoscopy; as part of this, a very small risk of bleeding (about 1 in 150) or a tiny risk of a hole forming in the bowel (about 1 in 1,500) exists. Remember, you can leave the study at any time without affecting your NHS care.

Locations (7)

Royal Victoria Infirmary
Approximate
Newcastle upon Tyne, United Kingdom
The Royal London Hospital
Approximate
London, United Kingdom
Addenbrooke's Hospital
Approximate
Cambridge, United Kingdom
Western General Hospital
City only
Lothian, United Kingdom
St Thomas' Hospital
Approximate
London, United Kingdom
Royal Devon & Exeter Hospital (wonford)
Approximate
Exeter, United Kingdom
St George's University Hospital
City only
London, United Kingdom

Common questions

What is the main goal of this study?

The main goal is to better understand Crohn's and colitis by looking at human cells and gut germs, to help develop better treatments and more personalised care in the future.

Who is funding this research?

The study is funded by EMBL Enterprise Management Technology Transfer GmbH, a company based in Germany.

Will taking part change my current medical treatment?

No, joining this study will not change the standard medical treatment you receive for your condition.

What kind of samples will be collected?

We will collect blood samples, stool samples (which you can do at home), and small tissue samples (biopsies) from your bowel during a colonoscopy.

What happens if I don't have Crohn's or Colitis after the first tests?

If you don't have Crohn's or colitis, no further research visits are needed, but we may check your medical records later to see if you develop symptoms.

How to find out more

Carol Shields

carol.shields@newcastle.ac.uk +44 (0)191 208 4870 Official trial record

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