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A novel method to detect Helicobacter pylori in children

检测儿童幽门螺杆菌的新方法

基本信息

批准号：
6800679
负责人：
DAVID A WAGNER
金额：
$ 33.21万
依托单位：
METABOLIC SOLUTIONS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2003
资助国家：
美国
起止时间：
2003-09-01 至 2006-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6800679
关键词：
Helicobacter blood tests carbon carbon dioxide clinical research diagnosis design /evaluation gastrointestinal disorder diagnosis gastrointestinal infection human subject oral administration pediatrics radiotracer stable isotope stable isotope diagnosis urease

项目摘要

DESCRIPTION (provided by applicant): In the avalanche of publicity surrounding H. pylori infection, children have been the one segment of the population that has been virtually ignored. However, there is a growing body of evidence that children, and especially minority children, are commonly afflicted with this disease. There are no FDA approved tests, other than the onerous endoscopic-based tests, to detect active H. pylori in children. We intend to address this need for a simple, minimally invasive and accurate diagnostic test for children. Metabolic Solutions has developed a test to determine the presence of active H. pylori infection that we named the Ez-HBT(TM). Although this is a blood test it should not be confused with serology tests that detect the presence of antibodies. The Ez-HBT(TM) is superior to antibody based tests because it detects the presence of gastric urease activity. Urease activity is only present when H. pylori have colonized the stomach. The test begins with the patient ingesting an oral dose of 13C-urea (non-radioactive label). The enzyme urease associated with gastric H. pylori breaks urea down into 13CO2 and ammonia. This results in an increase in the ratio of 13C/12C in blood carbon dioxide if H. pylori are present in the stomach. H. pylori infection impairs a child's growth, ability to function in school and may have long term implications for gastric cancer. The simplicity of the Ez-HBT(TM) including no test meal, a tablet that can be dissolved in a glass of water and a single traditional venipuncture makes it an ideal and cost effective tool for identifying H. pylori infection in children.

描述（由申请人提供）：在有关幽门螺杆菌感染的大量宣传中，儿童是几乎被忽视的人群之一。然而，越来越多的证据表明儿童，尤其是少数民族儿童，通常患有这种疾病。除了繁重的基于内窥镜的测试之外，没有 FDA 批准的测试来检测儿童中的活性幽门螺杆菌。我们打算满足儿童对简单、微创且准确的诊断测试的需求。 Metabolic Solutions 开发了一种测试来确定是否存在活动性幽门螺杆菌感染，我们将其命名为 Ez-HBT(TM)。尽管这是一项血液测试，但不应将其与检测抗体存在的血清学测试相混淆。 Ez-HBT(TM) 优于基于抗体的测试，因为它可以检测胃脲酶活性的存在。仅当幽门螺旋杆菌定植于胃中时，脲酶活性才存在。测试从患者口服 13C-尿素（非放射性标签）开始。与胃幽门螺杆菌相关的尿素酶将尿素分解为 13CO2 和氨。如果胃中存在幽门螺杆菌，这会导致血液二氧化碳中 13C/12C 的比率增加。幽门螺杆菌感染会损害儿童的生长、在学校的能力，并可能对胃癌产生长期影响。 Ez-HBT(TM) 的简单性包括无需测试餐、可溶解在一杯水中的片剂和一次传统静脉穿刺，使其成为识别儿童幽门螺杆菌感染的理想且具有成本效益的工具。