The PSC-Vanc Study
Primary sclerosing cholangitis (PSC) is a chronic liver disease of an unknown cause and with no effective medical treatment. Nearly three-quarters of people living with PSC also have a form of inflammatory bowel disease (PSC-IBD).
People with PSC-IBD appear to be at greater risk of colon cancer and the need for bowel surgery than people who don’t also have PSC.
Dr Nabil Quraishi (University of Birmingham, UK) recently discovered that the bacteria found in the bowel in people with PSC-IBD were very different to those with ulcerative colitis alone and healthy individuals. These bacteria had genes that were associated with converting bile acids into a form that can be absorbed into the colonic tissue. Analyses of genes obtained from biopsies of the colon from people with PSC-IBD suggested that the pathways that control the levels of bile acid in the colon were in a state of overdrive
These new findings raised several important questions in helping us understand how PSC and PSC-IBD develop and if these differences in the gut bacteria have anything to do with it.
Interestingly, an oral antibiotic called oral vancomycin has been shown to improve both liver blood tests and bowel inflammation in people with PSC-IBD. This antibiotic does not get absorbed so is its mode of action is possibly due to a change in the gut bacteria.
The PSC-Vanc Study
Dr Quraishi will lead a new study looking at vancomycin in PSC patients called the PSC-Vanc Study. The study team will recruit fifteen people with PSC-IBD who are having their annual colonoscopy. If they find inflammation in the bowel, those participants will be given 4 weeks’ of treatment with oral vancomycin. They will collect stool samples and colonic biopsies at different intervals. The team will then evaluate changes in the gut bacteria, the chemicals produced, bile acids and genes being expressed within the bowel. This will help us to identify specific disease pathways that are associated with PSC-IBD.
Why is this PSC study important?
Dr Quraishi said, “We don't know why vancomycin seems to work in PSC and PSC-IBD. The big question is are we doing something to the gut bacteria or bile acids that lead to a favourable shift. If so what is it and why? It’s a simple study but an important study to do. We are hoping to unlock and understand potential mechanisms for colitis and liver disease in PSC and if there are specific targets (such as bacteria, bile acids and genes) that can be translated into novel treatments for clinical trials.”
Can I take part in this study?
This study is based at the Queen Elizabeth Hospital (QEH) Birmingham. It is expected to begin in February 2022. It is open to anyone with PSC-IBD in the UK with mild to moderately active colitis and are due an IBD assessment/ colonoscopy.
As with other clinical trials, if your usual PSC hospital is not the QEH Birmingham, and you think you are suitable for this trial, talk to your PSC doctor. Some people switch hospitals temporarily for the duration of the clinical trial so that their PSC care and clinical trial study visits are at the same hospital; or they have a 'shared care' agreement whereby they still see their regular hospital doctor but also the PSC specialist who is running the clinical trial. Most PSC doctors will be supportive and coordinate this for you. We will add more details once the study opens for volunteers.