CompletedInterventional

PROFILE - personalised medicine in Crohn's disease

Crohn’s disease affects everyone differently. While some people have mild symptoms, others experience severe flare-ups that need strong medication early on. Currently, doctors cannot easily predict how severe someone’s condition will be. The PROFILE study aims to change this using a new blood test called a biomarker. This test looks at patterns in your blood to predict how your Crohn's might behave. Participants are adults aged 16 to 80 who have been diagnosed with Crohn’s within the past three months. Everyone in the study receives approved, active medication; no dummy treatments (placebos) are used. Half receive early intensive treatment with regular medicine infusions and tablets, while the other half follow standard NHS care where treatment is increased if needed. Researchers want to see if using the blood test to guide these decisions helps people stay well for longer.

At a glance

Status

Completed

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

400

Start

01 Dec 2017

Estimated completion

15 Dec 2021

Crohn’s disease

What is this study about?

Crohn’s disease is a lifelong condition that causes painful swelling and inflammation in parts of the digestive system. Because it affects every person differently, finding the right medication can sometimes take months of trial and error. Some people manage well with mild treatments, while others need stronger medicines straight away to prevent long-term bowel damage.

The PROFILE trial was set up to find out if a simple blood test can take the guesswork out of treatment. This test looks at specific markers in your blood, known as biomarkers. Researchers believe these markers can show right at diagnosis whether your Crohn’s is likely to be mild or severe. If doctors know this early on, they can give each person the treatment that suits them best from day one.

Everyone who takes part in the study receives well-tested, approved NHS treatments for Crohn’s disease. Participants are split into two groups. One group starts on an intensive course of medicine (an intravenous drip called infliximab along with daily tablets). The other group receives the current standard care, where stronger medicines are introduced step-by-step only if symptoms return or get worse.

By comparing these groups, the study hopes to show whether personalised care guided by a blood test leads to fewer flare-ups, fewer hospital visits, and a better quality of life. The findings could change how newly diagnosed Crohn's disease is treated across the NHS.

Key takeaways

The PROFILE trial tests whether a blood test can help personalise Crohn's disease treatment.
It is designed for people aged 16 to 80 who were diagnosed with Crohn’s within the last three months.
All participants receive active, approved medications; no placebos are used.
Participants are followed closely by specialist hospital teams for around one year.
Joining is completely voluntary, and you can withdraw at any time without harming your NHS care.

Who may be eligible?

This trial is open to people aged between 16 and 80 who have received a firm diagnosis of Crohn’s disease within the last three months. To be eligible, your Crohn’s must be currently active, which doctors check through regular blood or stool tests and camera examinations of your bowel. You must also be new to advanced Crohn's treatments, meaning you have not yet taken biologic drugs or immune-modifying tablets.

The study is not suitable for people with other forms of bowel disease, such as ulcerative colitis. It also excludes people who have severe complications needing urgent surgery, such as a major blockage in the bowel or deep infections (abscesses).

For safety reasons, you cannot join if you have a history of serious conditions like tuberculosis, hepatitis B or C, or cancer. The study is also not suitable for anyone who is currently pregnant or breastfeeding.

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 was diagnosed with Crohn’s disease within the last 3 months.
I am between 16 and 80 years old.
I currently have active symptoms or inflammation from my Crohn’s.
I have not previously taken biologic drugs or immune-modifying tablets.
I am not pregnant or breastfeeding.

Answer every question to see your result.

What does participation involve?

If you decide to join the study, you will be placed into one of two treatment groups by chance (randomly). If you are in the first group, you will receive an intensive treatment course involving about eight hospital visits over a year to receive infliximab through a drip, alongside daily tablets. If you are in the second group, you will start with standard NHS medications, and your doctor will step up your treatment if your symptoms do not improve. Throughout the year, you will attend regular hospital appointments for blood tests, stool checks, and symptom reviews so researchers can track how well your bowel is healing. Your total involvement lasts around one year.

Potential risks and benefits

A major benefit of taking part is that you will receive close monitoring from specialist bowel teams and prompt, active treatment for your Crohn’s disease without any placebos. However, like all medical treatments, the study medicines can cause side effects such as mild reactions during infusions or an increased risk of infections. Your care team will monitor you closely to catch and manage any problems early. Taking part is entirely voluntary, and you are free to leave the trial at any time without giving a reason and without it affecting your standard NHS care.

Locations (40)

Addenbrookes Hospital
City only
Cambridge, England
Barts and Royal London Hospital
City only
London, England
Bedford Hospital
Approximate
Bedford, England
Darlington Memorial Hospital
Approximate
Darlington, England
Derriford Hospital, Plymouth
Approximate
Plymouth, England
Epsom General Hospital
Unverified
Epsom, England
Glasgow Royal Infirmary
Unverified
Glasgow, Scotland
New Victoria Hospital, Glasgow
Unverified
Glasgow, Scotland
Gloucestershire Royal Hospital
Unverified
Gloucester, England
Guy's and St Thomas' Hospital
Unverified
London, England
Hull Royal Infirmary
Unverified
Hull, England
James Paget Hospital, Great Yarmouth
Unverified
Great Yarmouth, England

Common questions

Will I receive a dummy treatment (placebo)?

No. There are no placebos in this study. Every participant receives active, approved medications to treat their Crohn’s disease.

What is a biomarker?

A biomarker is a measurable biological sign found in the body, such as a specific protein or gene pattern in your blood. In this study, it acts like a clue to predict how active your Crohn's might be.

Are the medications new or experimental?

No. The medicines used in this study, including infliximab and immune-modifying tablets, are already widely used and approved for treating Crohn’s disease in the NHS.

How long will I be in the study?

Active involvement in the trial lasts for approximately one year, during which your treatment and health will be closely followed by the hospital team.

What happens if my Crohn’s gets worse during the study?

Your safety comes first. If your symptoms worsen at any point, your doctor can adjust your medication or change your treatment plan immediately.

How to find out more

Francis Dowling

francis.dowling@nhs.net +44 (0)1223 254 666 Official trial record

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