NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Limburg, Netherlands
Gastroenterology and Hepatology, Maastricht UMC+, Maastricht, Netherlands.
BMJ Open. 2024 Oct 7;14(10):e076290. doi: 10.1136/bmjopen-2023-076290.
Crohn's disease and ulcerative colitis are chronic inflammatory bowel diseases (IBD) with a relapsing-remitting nature. With adequate non-invasive prediction of mucosal inflammation, endoscopies can be prevented and treatment optimised earlier for better disease control. We aim to validate and recalibrate commonly used patient-reported symptom scores combined with a faecal calprotectin (FC) home test as non-invasive diagnostic tool for remote monitoring of IBD, both in daily practice and in a strict trial setting. Endoscopy will be used as the gold standard.
In this multicentre prospective validation study, adult IBD patients are asked to fill out questionnaires regarding disease activity (Monitor IBD At Home, mobile Health Index, Manitoba IBD Index, IBD control and patient-HBI/patient-Simple Clinical Colitis Activity Index), perform a FC home test and collect a stool sample for routine laboratory FC measurement, before the start of the bowel preparation for the ileocolonoscopy. Endoscopic disease activity will be scored according to the simplified endoscopic score for Crohn's disease (CD) for CD patients or Ulcerative Colitis Endoscopic Index for Severity and Mayo Endoscopic Subscore for ulcerative colitis patients. The main study outcome is the diagnostic test accuracy of the various patient-reported scores to assess mucosal inflammation in combination with a FC home test.
This study is approved by the Medical Research Ethics Committee of azM/UM in Maastricht dated 03 March 2021 (METC 20-085) and is monitored by the Clinical Trial Centre Maastricht according to Good Clinical Practice guidelines. Written informed consent will be obtained from all patients. Study results will be published in international peer-reviewed medical journals.
NCT05886322.
克罗恩病和溃疡性结肠炎是具有反复发作性质的慢性炎症性肠病（IBD）。通过对黏膜炎症进行充分的非侵入性预测，可以预防内镜检查，并更早地优化治疗，以更好地控制疾病。我们旨在验证和重新校准常用的患者报告症状评分，结合粪便钙卫蛋白（FC）家庭检测，作为 IBD 远程监测的非侵入性诊断工具，无论是在日常实践中还是在严格的试验环境中。内镜检查将作为金标准。
在这项多中心前瞻性验证研究中，要求成年 IBD 患者填写关于疾病活动度的问卷（在家监测 IBD、移动健康指数、马尼托巴 IBD 指数、IBD 控制和患者-HBI/患者-简单临床结肠炎活动指数），进行 FC 家庭检测，并收集粪便样本进行常规实验室 FC 测量，然后在准备进行回肠结肠内镜检查前。根据简化的克罗恩病内镜评分（CD）对 CD 患者或溃疡性结肠炎内镜严重程度指数和 Mayo 内镜结肠炎亚评分对溃疡性结肠炎患者进行内镜疾病活动评分。主要研究结果是各种患者报告评分与 FC 家庭检测相结合评估黏膜炎症的诊断测试准确性。
这项研究得到了马斯特里赫特 azM/UM 医学研究伦理委员会的批准（METC 20-085），并由马斯特里赫特临床试验中心根据良好临床实践指南进行监测。将从所有患者获得书面知情同意。研究结果将发表在国际同行评议的医学期刊上。
NCT05886322。
