Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

Unravelling intestinal fibrosis in ulcerative colitis: INTERACT study

The INTERACT study is designed for individuals living with ulcerative colitis. The main goal is to understand and track scarring (fibrosis) in the gut, which can be a serious problem for people with this condition. Researchers are using advanced methods, including a special type of scan called a FAPi PET/CT scan, alongside examining changes in cells and genes from small gut samples (biopsies). They want to see how these changes are connected over time, specifically looking at changes between the start of the study and 24 weeks later. By understanding these processes better, the hope is to pave the way for new and more effective treatments for gut scarring in ulcerative colitis. The study welcomes adults of any gender.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Amsterdam UMC

Enrolment target

Start

08 Dec 2023

Ulcerative colitis

What is this study about?

The INTERACT study is focused on ulcerative colitis, a condition where the large intestine becomes inflamed. Sometimes, this inflammation can lead to scarring, also known as fibrosis, in the gut. This scarring can make the condition harder to manage and can cause various problems. This study is trying to understand exactly how this scarring develops at a very detailed level, looking at tiny changes happening inside the cells of the gut.

Researchers will be using a combination of techniques. For example, they will take small samples (biopsies) from the gut to look at the genes and proteins within the cells. These are like the instruction manuals and building blocks of our bodies. They will also use a special type of scan, called a FAPi PET/CT scan. This scan helps them see and measure specific activities in the body that might be linked to scarring. By comparing the results from the biopsies and the scans at different times, they hope to get a clearer picture of how scarring progresses.

Understanding these processes is really important. If we can identify the specific pathways and changes that lead to gut scarring, it could help doctors develop new ways to diagnose it earlier and, crucially, to find better treatments to stop or even reverse the scarring. This could significantly improve the health and quality of life for people with ulcerative colitis.

Key takeaways

This study aims to understand gut scarring in ulcerative colitis.
It uses advanced scans and tissue samples to look at cell changes.
The research could lead to better ways to find and treat gut scarring.
It's for adults (18+) with ulcerative colitis, any gender.
Participation involves scans and biopsies over about 24 weeks.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for volunteers who have ulcerative colitis.

To be eligible, you must be 18 years old or older. The study is open to both men and women.

Beyond this basic information, there will likely be other specific health requirements or conditions that would determine if you can join. These details will be discussed carefully with potential participants by the study team to ensure it's the right fit for you.

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 diagnosis of ulcerative colitis?
Are you able to attend appointments for scans and biopsies?
Are you comfortable with the concept of medical scans (like PET/CT) and taking small tissue samples?
Are you willing to have your medical information used for research?
Are you able to commit to around 24 weeks of study involvement?

Answer every question to see your result.

What does participation involve?

If you join the INTERACT study, you'll have several visits over a period of time. At the start of the study, you would undergo initial assessments, which might include having a special scan (FAPi PET/CT scan) and having small tissue samples (biopsies) taken from your gut. These biopsies help researchers look closely at changes in your cells.

You would then continue with your regular care, and after about 24 weeks, you would likely have similar assessments repeated – another FAPi PET/CT scan and further biopsies. These repeat tests are crucial for the researchers to see how things have changed over time. The study will not involve new medication beyond what you might already be taking for your ulcerative colitis. The total duration of active participation for you would be around 24 weeks, with follow-up to ensure accurate data comparison.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is contributing to a better understanding of ulcerative colitis and gut scarring, which could lead to improved diagnosis and treatments for others in the future. You might also receive more frequent monitoring of your condition. Potential risks could include those associated with the FAPi PET/CT scan (like exposure to a small amount of radiation, similar to other medical scans) and the biopsy procedures (such as discomfort or very slight risk of bleeding or infection, as with any procedure of this type). You will be given a detailed explanation of all potential risks before deciding to join. It's important to remember that you are free to withdraw from the study at any time, for any reason, 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.

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Unverified
Netherlands

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the lining of the large intestine (colon and rectum) becomes inflamed and develops tiny ulcers. This causes symptoms like tummy pain and diarrhoea.

What is 'fibrosis'?

Fibrosis is another word for scarring. In ulcerative colitis, it means scarring in the gut, which can make the bowel stiff or narrow in places.

What is a FAPi PET/CT scan?

It's a special type of scan that helps doctors see what's happening inside your body at a very detailed level. It uses a small, safe amount of a substance that highlights specific areas. It’s similar to other scans you might have had but provides different information.

Will I get new medicine in this study?

No, this study is not testing a new medication. Its main purpose is to understand how scarring develops in the gut using scans and cell samples, rather than trying out a new drug.

Do I have to take part if I'm asked?

Absolutely not. Taking part in any research study is completely voluntary. You have the right to say no, and if you do join, you can leave at any time without it affecting your medical care.