PROFILE - personalised medicine in Crohn's disease

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.

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.