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

肠易激综合征(IBS)影响着北欧约12%的人口。在符合罗马III IBS标准的患者中，多达三分之一可能对小麦敏感，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)的诊断试验。在这项诊断准确性研究中，将评估共聚焦激光内窥镜(CLE)区分WS患者和非WS患者的预测能力。符合罗马III IBS标准的非乳糜泻患者将接受CLE的小麦诱导变化测试(指数测试)。对GFD有反应的IBS患者将被归类为WS(参考试验)。我们的研究旨在将CLE作为一种可靠的诊断工具来确定IBS患者的WS，这些患者将长期受益于GFD作为一种病因治疗。此外，WS诊断工具的建立将极大地促进未来对这种复杂疾病的发病机制和治疗的研究。

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.