Comparison of Patient Reported Disease Activity Scores Combined With Fecal Calprotectin Home Tests for Remote Monitoring of IBD Patients: a Multicenter Prospective Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 5
- 主要终点
- Recalibration of PROMs
研究概览
简要总结
Crohn's disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) with a heterogeneous disease course. Recurrent mucosal inflammation or chronic subclinical inflammation results in damage to the bowel and complications like stenosis, fistula and colorectal cancer. Therefore, tight control of mucosal inflammation is important to prevent complications.
The goal of this multicenter observational cohort study is to determine the best remote monitoring tool for predicting mucosal inflammation in adult patients with inflammatory bowel disease, relative to the gold standard endoscopy.
Participants will be asked to fill out questionnaires regarding disease activity (MIAH, mHI, IBD-control, Manitoba IBD Index, p-HBI/p-SCCAI), perform a FC home test and collect one stool sample for routine laboratory calprotectin measurement, before the start of the bowel preparation for the ileocolonoscopy. During this ileocolonoscopy, endoscopic disease activity will be determined.
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研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of CD or UC according to ECCO guidelines
- •CD or UC patients scheduled for an ileocolonoscopy, or UC patients scheduled for an sigmoidoscopy at the endoscopy ward of one of the participating centers (regardless of indication)
- •Aged 18 years or older
- •Smartphone with internet access (for use FC home test)
排除标准
- •Unclassified IBD
- •Ileostomy, colostomy, ileoanal pouch anastomosis or ileorectal anastomosis
- •Isolated upper gastro-intestinal CD, or isolated peri-anal disease
- •Insufficient knowledge of Dutch language
结局指标
主要结局
Recalibration of PROMs
时间窗: week 0 (i.e. in the week before the colonoscopy)
Recalibrate PROMs with the FC home test to optimise prediction of mucosal inflammation, relative to the gold standard ileocolonoscopy, for use in daily clinical practice
Prediction of mucosal inflammation in daily clinical practice with PROMs and FC home test
时间窗: week 0 (i.e. in the week before the colonoscopy)
次要结局
- Agreement between FC home test and routine laboratory tests(week 0-1 (i.e. FC home test in the week before the colonoscopy and the laboratory test at the day of the colonoscopy))
- Association between IBD-control and histologic disease activity(week 0-1)
- prediction of mucosal inflammation in strict trial setting with PROMs and FC home test(week 0 (i.e. in the week before the colonoscopy))
- Association between clinical (abdominal pain) and histologic disease activity(week 0-1)