ISRCTN96296121进行中（未招募）未知
Defining microbial predictors of responsiveness to biologic therapies in Crohn’s disease and ulcerative colitis
ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 1,325 人开始时间: 2021年12月29日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,325
研究概览
简要总结
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38631839/ (added 18/04/2024)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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.
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