A Novel Diagnostic Test for Irritable Bowel Syndrome

描述(申请人提供)：肠易激综合征(IBS)是一种改变生活的肠道疾病，影响大约20%的普通人群。对于IBS的阳性确认，没有单一的诊断试验。医生根据使用标准内窥镜检查排除结构或生化异常、体检和症状问卷的方案得出LBS诊断。这一效率低下的过程导致了医疗资源的大量使用，估计有350万次办公室就诊和220万次处方，每年直接和间接成本为290亿美元。 我们的目标是开发一种易于使用、低成本的呼吸测试来诊断LBS。由代谢解决方案公司(MSI)开发的这项测试是基于LBS患者对果糖吸收不良的原理。在初步研究中，MSI已经展示了一种新的技术，使用碳13示踪剂和未标记的果糖来识别患有LBS的人，通过他们是否能够吸收注射的果糖。这是第一个直接从小肠检测果糖吸收不良并将其与LBS诊断相关联的测试。 拟议中的检测将显著减少国家医疗保健支出，因为适当的诊断将减少办公室就诊，更谨慎地使用药物，并为大量美国人带来更好的总体健康和福祉。

DESCRIPTION (provided by applicant): Irritable Bowel Syndrome (IBS) is a life altering disorder of the intestines that effects approximately 20 percent of the general population. There is no single diagnostic test for positive confirmation of IBS. Physicians arrive at an lBS diagnosis following a protocol that uses standard endoscopic tests to exclude structural or biochemical abnormalities, a physical examination and a symptom questionnaire. This inefficient process leads to an enormous use of healthcare resources estimated at 3.5 million office visits and 2.2 million prescriptions at a direct and indirect cost of $29 billion annually. Our objective is to develop an easy to use, low cost breath test to diagnosis lBS. The test developed by Metabolic Solutions (MSI) is based on the principle that lBS patients malabsorb fructose. In preliminary studies MSI has demonstrated a novel technology using a carbon 13 tracer and unlabeled fructose to identify individuals with lBS by whether or not they can absorb the administered fructose. This is the first test to assay fructose malabsorption directly from the small intestine and correlate it to the diagnosis of LBS. The proposed test will significantly reduce national health care expenditures because proper diagnosis will lead to fewer office visits, more prudent use of drugs and better general health and well-being for a large number of Americans.