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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Victoria
Hildreth
-
IBD.Response@newcastle.ac.uk
Dr
Christopher
Lamb
-
christopher.lamb@newcastle.ac.uk
Dr
Dean
Allerton
-
IBD.Response@newcastle.ac.uk
Dr
Naomi
McGregor
-
IBD.Response@newcastle.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Crohn’s disease and ulcerative colitis
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Crohn's disease and ulcerative colitis (UC) are types of a bowel condition known as inflammatory bowel disease (IBD) and the symptoms (diarrhoea, pain, fatigue) have a major impact on daily life. IBD affects around 1 in 125 people in the UK and this is expected to rise to 1 in 100 by 2028. "Biologics" are powerful medications that are given to reduce inflammation in IBD. These treatments can be effective but up to 40% of patients don't respond, and in those that do, many don't respond well enough to stay on the drug after one year of treatment. Unfortunately, we have no way to predict which patients are most likely to benefit from treatment (known as responders), and we do not fully understand how medications work in responders. As these drugs may have serious side effects and are expensive to the NHS, this lack of understanding is a major obstacle in deciding which treatment is best to give to an individual patient, and when to give it to them in order to have the greatest benefit and the least risk. Recent data from small studies in people with IBD and larger studies of people with cancer, show that certain bacteria in stool may predict who will respond or fail to respond to treatments.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38631839/ (added 18/04/2024)
You can take part if:
You may not be able to take part if:
1. Receiving oral corticosteroids for any indication where the dose is unlikely to be weaned by week 14.2. Planned bowel resection surgery within 14 weeks of commencing therapy.3. Biologic or JAKi being commenced as rescue therapy for acute severe ulcerative colitis (ASUC).4. Biologic or JAKi being commenced as part of CTIMP.5. Ileal pouch anal anastomosis.6. Presence of a stoma.7. Perianal Crohn’s disease in absence of active luminal inflammation.8. Faecal microbial transplantation (FMT) within the preceding 12 weeks or planned FMT within 14 weeks of commencing biologic or JAKi.9. Antibiotics or short-term (<=4 weeks) course of probiotics within the preceding 2 weeks.10. NOTE: Use of long-term (>4 weeks), stable doses of probiotics is not an exclusion from this study but should be noted in the CRF. Use of antibiotics or prior FMT outside of the exclusion time period are not exclusions. Antibiotic use in the preceding 1 year and ever having received FMT will be noted in the CRF.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Christopher
Lamb
-
christopher.lamb@newcastle.ac.uk
Dr
Dean
Allerton
-
IBD.Response@newcastle.ac.uk
Dr
Naomi
McGregor
-
IBD.Response@newcastle.ac.uk
Dr
Victoria
Hildreth
-
IBD.Response@newcastle.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Newcastle upon Tyne Hospitals NHS Foundation Trust and funded by Medical Research Council; Leona M. and Harry B. Helmsley Charitable Trust.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 49964
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
