Prospective, double-blind diagnostic study of confocal laser endomicroscopy (CLE) forwheat sensitivity (WS) in patients with irritable bowel syndrome

共聚焦激光内窥镜 (CLE) 对肠易激综合征患者小麦敏感性 (WS) 的前瞻性、双盲诊断研究

• 批准号: 276697502
• 负责人: Professor Dr. Christian Bojarski
• 金额: --
• 依托单位: Praxis für Gastroenterologie Köln
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2016
• 资助国家: 德国
• 起止时间: 2015-12-31 至 2019-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/276697502?language=en
• 关键词: Prospective; double; blind; diagnostic; study

The irritable bowel syndrome (IBS) affects about 12% of the population in Northern Europe. Up to one third of patients fulfilling the Rome III criteria of IBS may be wheatsensitive and respond to a gluten-free diet (GFD) although they do not have celiac disease. However, a diagnostic test for wheat sensitivity (WS) is missing. In this diagnostic accuracy study the predictive ability of confocal laser endomicroscopy (CLE) to discriminate between patients with and without WS will be evaluated. Nonceliac patients fulfilling the Rome III criteria for IBS will be tested by CLE for wheatinduced changes (index test). IBS patients responding to GFD will be classified as having WS (reference test). Our study aims to establish CLE as a reliable diagnostic tool to identify WS in IBS patients who would profit long-term from GFD as a causative treatment. Furthermore, the establishment of a diagnostic tool for WS would greatly facilitate future investigations into the pathogenesis and treatment of this complex disorder.

肠易激综合征（IBS）影响北方欧洲约12%的人口。符合罗马III标准的IBS患者中，有多达三分之一的患者可能对小麦过敏，并对无麸质饮食（GFD）有反应，尽管他们没有乳糜泻。然而，缺少小麦敏感性（WS）的诊断测试。在这项诊断准确性研究中，将评价共焦激光显微内镜（CLE）区分WS患者和非WS患者的预测能力。符合IBS罗马III标准的非乳糜泻患者将通过CLE测试小麦诱导的变化（指数测试）。对GFD有反应的IBS患者将被分类为具有WS（参考测试）。我们的研究旨在建立CLE作为一种可靠的诊断工具，以确定IBS患者中的WS，这些患者将从GFD作为病因治疗中长期获益。此外，建立一个诊断工具，WS将大大有利于未来的调查发病机制和治疗这种复杂的疾病。