Development of new non-invasive tests for inflammatory bowel disease detection, monitoring and treatment assessment.

炎症性肠病(IBD)是一组常见的与肠炎症有关的慢性疾病。溃疡性结肠炎和克罗恩病是本组最重要的疾病。IBD通常在年轻人中被诊断出来。一般来说，它的特点是长时间飞行和需要治疗的偶发性突发事件。IBD应该与非炎症性功能障碍，特别是与极其常见的肠易激综合征(IBS)区分开来，但目前还没有可靠的非侵入性测试可用于这一目的。目前，欧洲约有240万IBD患者，英国高达24万。所有人都应该接受监测，看是否有复发的可能。那些复发的患者会得到治疗；因此，治疗选择、治疗充分性和有效性评估以及长期监测是需要认真改进的重要任务。诊断节点有限公司开发了一种自然开肠后从肛门区非侵入性收集生物材料的新方法。这种基于样本自我收集的简单程序是非侵入性的，而且是安全的。收集的材料主要来自大肠粘液。它含有丰富的细胞，可用于诊断生物标志物测试。拟议的试点临床试验重点是比较各种蛋白质生物标志物的性能，用于：a)通过比较60名IBD患者和60名IBS患者组来检测IBD；b)IBD组的治疗充分性和有效性评估；c)通过对IBD组的随访来监测IBD。通过实验室分析获得的试验结果将确定最适合制作一系列产品原型的蛋白质生物标记物，包括针对IBD诊断、治疗方式选择、治疗效率评估和监测的护理点和实验室测试。

Inflammatory bowel disease (IBD) is a group of common chronic diseases involving bowelinflammation. Ulcerative colitis and Crohn’s disease are the most important conditions of thisgroup. IBD is usually diagnosed in young adults. As a rule it is characterized by longremissions and incidental flare-ups requiring treatment. IBD should be distinguished from noninflammatoryfunctional disorders, in particular from extremely common irritable bowelsyndrome (IBS), but there is no reliable non-invasive test available for this purpose.Currently there are about 2.4 million IBD patients in Europe and up to 240,000 in the UK. Allof them should be monitored for possible relapses. Those developing relapses are treated;therefore treatment choice, treatment adequacy and efficiency assessment and long-termmonitoring are important tasks in need of serious improvements.DiagNodus Ltd has developed a new method of non-invasive collection of biological materialfrom the anal area following natural bowel opening. This simple procedure based on sampleself-collection is non-invasive and safe. The collected material predominantly derives fromcolorectal mucus. It contains cells in abundance and can be used for diagnostic biomarkertesting.The proposed pilot clinical trial is focused on comparatively evaluating performance of arange of protein biomarkers for: a) IBD detection by comparing groups of 60 patients withIBD and 60 patients with IBS; b) IBD treatment adequacy and efficiency assessment in theIBD group; c) IBD monitoring by following-up the IBD group. The results of the trialobtained by laboratory analysis will identify the most suitable protein biomarkers forprototyping a family of products including point-of care and laboratory tests for IBDdiagnosis, therapeutic modality choice, treatment efficiency assessment and monitoring.