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

炎症性肠病（Inflammatory Bowel Disease，IBD）是一组常见的以肠道炎症为主要表现的慢性疾病.溃疡性结肠炎和克罗恩病是最重要的条件，这组。IBD通常在年轻人中诊断。一般来说，它的特点是长期缓解和偶然发作，需要治疗。IBD应区别于非炎症性功能性疾病，特别是与极其常见的肠易激综合征（IBS），但没有可靠的非侵入性检测可用于此目的。目前，在欧洲约有240万IBD患者，在英国高达24万。所有这些都应该被监控，以防复发。那些发展中的复发治疗;因此治疗选择，治疗充分性和有效性评估和长期监测是需要认真改进的重要任务。DiagNodus有限公司开发了一种新的方法，非侵入性收集生物材料从肛门区域后，自然肠道开放。该方法简单、无创、安全。收集的物质主要来自结直肠粘液。它含有丰富的细胞，可用于诊断生物标志物testing.The拟议的先导性临床试验的重点是比较评估性能的一系列蛋白质生物标志物：a）IBD检测通过比较组60例IBD和60例IBS患者; B）IBD治疗充分性和效率评估在IBD组; c）IBD监测通过后续IBD组。通过实验室分析获得的试验结果将确定最合适的蛋白质生物标志物，用于原型设计一系列产品，包括用于IBD诊断，治疗方式选择，治疗效率评估和监测的即时护理和实验室测试。

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.