RecruitingObservational

Identifying features contributing to the development and progression of primary sclerosing cholangitis

Primary sclerosing cholangitis (PSC) is an uncommon condition where the bile ducts inside and outside the liver become inflamed and scarred. Over time, this damage can lead to liver complications, but doctors still do not fully understand why it happens or how to stop it. This study, led by the University of Birmingham, aims to uncover the causes of PSC and find targets for new medicines. Researchers are gathering blood and stool samples from adults with PSC, related liver conditions, inflammatory bowel disease (IBD), and healthy volunteers. If you already have a routine hospital camera test scheduled for your bowel or bile ducts, doctors may also collect small extra tissue samples during your normal care. Taking part will not directly change your current medical care, but your involvement could help scientists develop more effective treatments for people living with liver disease in the future.

At a glance

Status

Recruiting

Sponsor

University of Birmingham

Enrolment target

350

Start

15 Nov 2024

Estimated completion

30 Nov 2031

Primary sclerosing cholangitis

What is this study about?

Primary sclerosing cholangitis (PSC) is a long-term condition affecting the bile ducts—the small tubes that carry digestive juices from your liver to your gut. In people with PSC, these ducts become inflamed and scarred. This causes bile to build up, which can damage the liver over time. While medical understanding has improved, doctors still do not know what triggers the condition or why it gets worse in some people faster than others.

To find these answers, researchers at the University of Birmingham are running an observational study. This means they are not testing any experimental drugs. Instead, they are collecting biological samples—such as blood, stool, and small tissue samples—from people with liver disease, people with bowel disease, and healthy volunteers. Scientists will look closely at the cells and molecules in these samples to see what makes people with PSC different from those with other conditions or healthy individuals.

There are currently very few treatments that can slow down or reverse PSC. By studying these samples in detail, researchers hope to discover the exact biological pathways involved in the disease. This vital information could guide doctors toward new, targeted treatments that could improve life for people with PSC in the years to come.

Key takeaways

The study explores why primary sclerosing cholangitis (PSC) develops and how it progresses over time.
Open to adults aged 18 to 75 with PSC, related liver conditions, IBD, or healthy volunteers.
Involves one 30-minute visit in Birmingham to give a blood sample and receive a home stool kit.
Extra tissue samples are only collected if you already need a routine camera test for your regular NHS care.
Taking part is entirely voluntary, does not involve new medications, and you can withdraw at any time.

Who may be eligible?

This study is open to adults aged 18 to 75 who can attend an appointment at the Queen Elizabeth Hospital in Birmingham. Researchers are inviting people who have an established diagnosis of primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), or metabolic-associated steatotic liver disease (MASLD, formerly known as fatty liver disease).

You may also be eligible if you have inflammatory bowel disease (IBD)—such as ulcerative colitis or Crohn’s disease affecting your large bowel—even if you do not have liver disease. In addition, the team is looking for healthy volunteers who have no history of liver or bowel problems, as this helps scientists compare healthy samples with those from people who are unwell.

To take part, you must be able to give your informed consent, attend a brief hospital visit, and fill out short health questionnaires. You will only be asked to provide tissue samples from camera tests if you already need those procedures as part of your regular NHS care.

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.

I am between 18 and 75 years of age.
I am able to travel to the Queen Elizabeth Hospital in Birmingham for a 30-minute visit.
I have PSC, PBC, MASLD, or IBD, or I am a healthy volunteer with no liver or bowel disease.
I am willing to provide a blood sample (around seven teaspoons) and complete a home stool collection kit.
I feel comfortable understanding the study information and filling out health questionnaires.

Answer every question to see your result.

What does participation involve?

Taking part is designed to fit around your usual routine. You will attend a single 30-minute screening visit at the Queen Elizabeth Hospital in Birmingham. During this visit, a researcher will go through the study details with you, answer your questions, and ask you to sign a consent form. You will be asked to give a blood sample of up to 35 millilitres (about seven teaspoons) and complete a short questionnaire. You will also receive a simple stool collection kit to use at home and return to the hospital.

There are no trial drugs to take, and your regular medical care will stay exactly the same. If you already have a routine hospital camera test booked—such as a colonoscopy (to look inside your bowel) or an ERCP (to look at your bile ducts)—the doctor carrying out the test will ask if they can take a few small extra tissue or fluid samples. You will never be asked to have an endoscopy or camera test purely for this research. The study as a whole runs until November 2031, but your active participation only involves providing your samples.

Potential risks and benefits

Taking part will not directly improve your health or alter your current treatment, but your contribution could help researchers discover better ways to diagnose and treat liver conditions in the future. The risks of joining are very low. Giving a blood sample may cause brief discomfort, slight bruising, or mild faintness. If you already have a routine camera test booked and agree to give extra tissue samples, there is a very small risk of bleeding (around 1 to 6 in 1,000 for a colonoscopy, and about 1 in 5,000 for an ERCP), which rarely requires treatment such as a blood transfusion. You are completely free to choose which samples you provide, and you can withdraw from the study at any time without your regular NHS care being affected.

Locations (1)

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

University Hospitals Birmingham NHS Foundation Trust
City only
Birmingham, England

Common questions

Will taking part change my current treatment or medication?

No. This is an observational study, which means no experimental treatments are given. Your usual NHS prescriptions and clinical care will carry on without changes.

Do I have to undergo a camera test to join the study?

No. You will only provide tissue or fluid samples if you are already scheduled to have a colonoscopy or bile duct test as part of your normal medical care.

Can I take part if I do not have a liver condition?

Yes. Researchers need healthy volunteers and people with inflammatory bowel disease to compare their samples against those from people with liver disease.

What happens if I change my mind after signing up?

You are free to leave the study at any point. You do not need to give a reason, and stepping down will not affect your relationship with your healthcare team or your treatment.

Where does the study take place?

The study visit takes place at the Queen Elizabeth Hospital in Birmingham, run by the University of Birmingham Liver Unit.

How to find out more

Palak Trivedi

p.j.trivedi@bham.ac.uk +44 1213718173 Official trial record

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