Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from the ISRCTN registry eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 16 years or older.
• People with a confirmed diagnosis of inflammatory bowel disease (IBD), including Crohn's disease, ulcerative colitis, or a type called IBD-U.
• People who are willing and able to give their informed consent to take part.
• People who are willing to complete questionnaires, collect stool samples at home, and provide additional biological samples during hospital visits.
• People whose clinical team is planning to start them on one of the following treatments for active IBD affecting the gut: a biologic medicine (infliximab, adalimumab, vedolizumab, or ustekinumab) or a type of tablet called a JAK inhibitor (tofacitinib, filgotinib, or upadacitinib) or a medicine called ozanimod.
• People with Crohn's disease who also have at least one of the following recorded in the past 16 weeks: a stool test result showing raised inflammation (faecal calprotectin of 250 or above), a blood test showing raised inflammation (CRP of 6 or above), scan results showing active inflammation, or a camera test (endoscopy) showing active Crohn's disease with ulcers.
• People with ulcerative colitis who also have at least one of the following recorded in the past 16 weeks: a stool test result showing raised inflammation (faecal calprotectin of 250 or above), a blood test showing raised inflammation (CRP of 6 or above), or a camera test (endoscopy) showing at least moderately active ulcerative colitis.
• People who have previously been treated with biologic medicines are still eligible — prior biologic treatment is not a barrier to joining.

Who may not be able to join:

• People who are currently taking steroid tablets (such as prednisolone) where it is unlikely the dose will be reduced by around week 14 of the study.
• People who have planned bowel surgery within 14 weeks of starting their new treatment.
• People whose biologic or JAK inhibitor is being started as an emergency treatment for a severe sudden flare of ulcerative colitis (known as acute severe ulcerative colitis).
• People whose biologic or JAK inhibitor is being started as part of a separate clinical drug trial (CTIMP).
• People who have had a surgical procedure where the bowel is connected to the back passage after pouch formation (ileal pouch anal anastomosis).
• People who have a stoma (a surgical opening where waste exits through the abdomen into a bag).
• People who have Crohn's disease only around the back passage (perianal Crohn's disease) with no active inflammation inside the gut.
• People who have had a faecal microbiota transplant (a procedure using donor stool) in the past 12 weeks, or who have one planned within 14 weeks of starting their new treatment.
• People who have taken antibiotics or a short course of probiotics (lasting 4 weeks or less) within the past 2 weeks.
• People who are known carriers of blood-borne viruses, including HIV or Hepatitis C, that would prevent safe handling of samples at the central laboratory.

Important: Always verify eligibility with the trial site directly before applying.