Crohn’s disease and ulcerative colitis Digestive System
Conditions
Interventions
Current interventions as of 19/12/2024:
This is a multi-centre, observational cohort study with 40 centres across the United Kingdom. We will aim to recruit 1325 participants over 27 months. Patient
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 30/10/2025: 1. Adults aged 16 years and over. 2. Established diagnosis of inflammatory bowel disease: Crohn’s disease, ulcerative colitis or IBD-U. 3. Willing and able to provide informed consent. 4. Willing to undertake the following study procedures: 4.1. Completion of questionnaires. 4.2. Collection of stool specimens at home. 4.3. Provision of the requested biosamples during visits to hospital. 5. Intention of clinical team to commence anti-TNFa (infliximab or adalimumab), anti-integrin (vedolizumab), anti-IL12/23 (ustekinumab) biologic or JAKi (tofacitinib, filgotinib or upadactinib)/SP1 receptor modulator (ozanimod) therapy, for active luminal IBD. 6. Additional inclusion criteria for patients with Crohn’s disease 7. Patients with Crohn’s disease must have at least one of the following documented within 16 weeks prior to consent: 8. Faecal calprotectin >=250 µg/g. 9. CRP >=6 mg/L. 10. Any endoscopic evidence of active Crohn’s disease, defined as ulceration (with at least one ulcer >=5mm) judged locally from available clinical data (as an approximation equivalent to SES-CD of >=4 for ileal disease or >=6 for ileocolonic or colonic disease. This can be estimated retrospectively from clinical record and does not have to be prospectively calculated). Participants with endoscopic evidence of jejunal disease can also be recruited. 11. Active inflammatory disease on imaging (MRI/CT/ultrasound) judged locally from available clinical data. 12. Additional inclusion criteria for participants with ulcerative colitis 13. Patients with ulcerative colitis must have at least one of the following documented within 16 weeks prior to consent: 14. Faecal calprotectin >=250 µg/g 15. CRP >=6 mg/L 16. Any endoscopic evidence of at least moderately active ulcerative colitis (of any extent including proctitis), defined as features of Mayo endoscopy sub-score > = 2 (marked erythema, lack of vascular pattern, friability, erosions, spontaneous bleeding or ulceration). This assessment will be judged locally and retrospectively from available clinical data and does not have to be prospectively calculated. 17. NOTE: Patients do not have to be biologic-naïve. Any additional biologics or small molecule newly licensed for Crohn’s disease or ulcerative colitis during the IBD-RESPONSE planned study period will also be suitable to allow inclusion. _____ Previous key inclusion criteria: 1. Adults aged 16 years and over. 2. Established diagnosis of inflammatory bowel disease: Crohn’s disease, ulcerative colitis or IBD-U. 3. Already participating or willing to participate in IBD BioResource. 4. Willing and able to provide informed consent. 5. Willing to undertake the following study procedures: 5.1. Completion of questionnaires. 5.2. Collection of stool specimens at home. 5.3. Provision of the requested biosamples during visits to hospital. 6. Intention of clinical team to commence anti-TNFa (infliximab or adalimumab), anti-integrin (vedolizumab), anti-IL12/23 (ustekinumab) biologic or JAKi (tofacitinib) therapy, for active luminal IBD within 6 weeks. 7. Additional inclusion criteria for patients with Crohn’s disease 8. Patients with Crohn’s disease must have at least one of the following documented within 12 weeks prior to consent: 9. Faecal calprotectin >=250 µg/g. 10. CRP >=6 mg/L. 11. Any endoscopic evidence of active Crohn’s disease, defined as ulceration (with at least one ulcer >=5mm) judged locally from available clini
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 30/10/2025: 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), 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. _____ Previous key exclusion criteria: 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), 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Stool frequency and rectal bleeding measured by PRO-2 at 14 weeks 2. Absence of rectal bowel surgery up to 14 weeks (yes/no) measured using patient records 3. Use of oral corticosteroids at 14 weeks (yes/no) measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 30/10/2025: 1. Stool frequency and rectal bleeding measured by PRO-2 at baseline, week 14, and week 54 2. Absence of rectal bowel surgery up to 54 weeks (yes/no) measured using patient records 3. Use of oral or intravenous corticosteroids at 14 weeks and 54 weeks (yes/no) measured using patient records 4. Time to treatment escalation (if applicable) up to 54 weeks measured using patient records, defined as: 4.1 Biologic or JAKi switch due to lack of efficacy/those with loss of response (does not include biosimilar switch or switch from i.v. to s.c.). 4.2 Dose intensification of drug due to lack of efficacy (does not include intensification based on therapeutic drug monitoring without flare in responders). 4.3 Re-sectional intestinal surgery (does not include examination under anaesthesia procedures in patients with perianal Crohn’s disease). 4.4 Induction or dose escalation of corticosteroids. 5. Time to discontinuation of index drug (if applicable) up to 54 weeks measured using patient records 6. Adverse events up to 54 weeks measured using patient records 7. Development of anti-drug antibodies measured using blood test at week 14 and 54 8. C-reactive protein (CRP) measured using blood test at baseline, week 14, and week 54 9. Faecal calprotectin measured using stool sample at baseline, week 14, and week 54 10. Remission measured by endoscopy during follow up (Mayo endoscopic subscore =1 for ulcerative colitis or SES-CD =2 for Crohn’s disease) 11. Quality of life measured using EQ-5D-5L and IBD-Control questionnaires at baseline, week 14, and week 54 12. Physical activity measured using International Physical Activity Questionnaire (IPAQ) at baseline, week 14, and week 54 13. Dietary intake measured using the Scottish Collaborative Group Food Frequency Questionnaire (FFQ) and the Kings College London 4-day food diary for CD-metaRESPONSE sub cohort participants only, at baseline, week 14, and week 54 14. Fatigue measured us | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed