IBD-RESPONSE – predicting treatment response in Crohn’s disease and ulcerative colitis

Not Applicable

• Conditions: Crohn’s disease and ulcerative colitis; Digestive System

• Registration Number: ISRCTN96296121
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38631839/ (added 18/04/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-29
• Last Update Posted: 15 July 2024
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1325

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 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).
12. Active inflammatory disease on imaging (MRI/CT/ultrasound) judged locally from available clinical data.
13. Additional inclusion criteria for participants with ulcerative colitis
14. Patients with ulcerative colitis must have at least one of the following documented within 12 weeks prior to consent:
15. Faecal calprotectin >=250 µg/g
16. CRP >=6 mg/L
17. 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.
18. 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.

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) 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.

Study & Design

• Study Type: Observational
• Study Design: Not specified