Taking part in this study involves completing questionnaires and collecting samples at three different timepoints over 54 weeks. Assessment timepoints have been selected to coincide where possible with when you would receive doses of your prescribed treatment.
You will be prompted to complete questionnaires and provide stool samples at the appropriate time e.g., by text message, email or telephone call.If you decide you would like to take part in the study, you will be asked to provide or confirm your email address so that a link to our online database can be sent to you.
The database that we are using is called REDCap. This is managed by the Newcastle upon Tyne Hospitals NHS Foundation Trust and will give you access to provide your consent to be part of the study, access to all the study questionnaires and send you reminders to complete the questionnaires when required.
These can be completed on a mobile phone, tablet, computer or laptop. If you are completing the consent process remotely (for many people this will be in your home), a member of the local study team will be in contact with you by telephone to talk through the consent process.
Questionnaires: we will ask you to complete a series of questionnaires over 4 days at each of the 3 study assessment periods. These include questionnaires that will ask you about your symptoms including stool frequency, bleeding, pain and tiredness, as well as the impact that your condition is having on your quality of life, including your physical activity levels and mental health.You will also be asked to provide details about your diet over the previous 2-3 months which will take approximately 30 minutes to complete.
You will receive reminders by email and text message with your consent to complete the questionnaires at each of the time points.We will also collect some additional information from your medical notes including relevant medical history, current and previous medications and lifestyle details such as smoking habits and vocation.
We will collect the first part of your current postcode and the first part of your postcode at the time of your diagnosis. These details will be collected by the team at your local hospital using your medical notes, however you may be asked to confirm answers to questions the research team are unsure about.
The study also involves collecting samples, including stool at home, blood when you come to hospital for visits as part of your routine care, and biopsies only if you come for an endoscopy as part of your routine care during the time you take part in the study.
Stool samples:
You will be provided with a ‘home collection’ kit from the study team to collect your stool samples. These sample kits may be given to you when you are at the hospital attending your appointment or may be sent to you by post.
The kits will contain all you need to collect a stool sample at home, including instructions. It will also have freepost, pre-addressed, Royal Mail return packaging that you can use to send your stool sample to the Newcastle University research laboratory.
You will be asked to collect one stool to transfer to two tubes for the study.
Blood samples: If you are attending the hospital for a clinical appointment prior to starting treatment (assessment 1) or within 10-20 weeks after commencing treatment (assessment 2), you will be asked to provide a blood sample at each visit.
We will collect approximately 20mL of blood (approximately 4 teaspoons), which will be sent to members of the IBD-RESPONSE team at the Wellcome Sanger Institute in Cambridge by the study team at your hospital site. Researchers at the Wellcome Sanger Institute will look at the genetic information in your blood sample.
Remaining blood (including plasma, the liquid part of blood that carries cells), will be sent to Newcastle University for analysis and biobanking (storing for future research use). If you do not attend a routine appointment within either of the assessment time points, blood samples will not be taken.
Biopsy samples: If you are scheduled to have a colonoscopy or flexible sigmoidoscopy while you are participating in the study, we will ask to collect additional research biopsy samples from the part of your intestine affected by Crohn’s or colitis; your colon (large intestine) and/or terminal ileum (small intestine). We will also collect some details about your disease severity at the time of the colonoscopy or flexible sigmoidoscopy.
Samples of tissue are already routinely taken during these procedures as part of standard Crohn’s and colitis NHS care, but we will ask to collect up to 12 additional biopsy samples in total (6 from the colon in all patients and a further 6 from the terminal ileum in Crohn’s participants). Biopsy samples will be sent to the Wellcome Sanger Institute and Newcastle University for analysis.
Any remaining biopsy tissue will be stored at Newcastle University for use in future research (biobanked). If you are booked in for an endoscopy at the same time as your study assessment, we will ask you to collect your stool samples and complete questionnaires before, or 2 weeks after, your endoscopy. This is because the bowel preparation/cleansing that you need to take for the procedure may have an impact on your gut microbes for up to 2 weeks.
As part of this study we will also ask permission to access samples stored by the NHS from previous endoscopies or operations you may have had to undertake research. We would also like to be able to access endoscopy images or videos from previous procedures you have had or have during this study.
