跳至主要内容
临床试验/NCT03324763
NCT03324763已完成不适用

Study of the Performances of a Fast Diagnosis Immunochromatographic Test for the Detection of Helicobacter Pylori (H. Pylori) Antigens in Child Stool

Lille Catholic University1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2014年3月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
158
试验地点
1
主要终点
Performance of a new quick, noninvasive, one-step immuno-chromatographic, stool antigen test France) for the detection of H. pylori infection in children

研究概览

简要总结

The diagnostic tests used to detect Helicobacter pylori (H. pylori) infection are either direct and invasive, as in culture, histology and the rapid urease test (RUT) or noninvasive, such as serology, the 13C-Urea breathe test or the stool antigen test. However, there is no single reference method to detect the H. pylori infection reliably and accurately. The specificity of gastric biopsy cultures is 100%, but the sensitivity is lower. Histology and RUT provide excellent diagnostic accuracy, but the detection of H. pylori is decreased in cases of bleeding peptic ulcers or gastric atrophy. Therefore, it is recommended that at least two tests should agree when defining the H. pylori infection in children. Quantitative real-time polymerase chain reaction (qPCR)-based methods have been shown to be the most reliable for H. pylori detection in adults and in children. In children, the reference method for H. pylori infection detection is invasive, namely upper digestive endoscopy with gastric biopsy for histology, culture, RUT and qPCR. A noninvasive alternative to detect H. pylori antigen in stools could use a quick one-step immuno-chromatographic technique.

The aim of this study was to assess the performance of a new quick, noninvasive, one-step immuno-chromatographic, stool antigen test (ALERE Inc, Jouy-en-Josas, France) for the detection of H. pylori infection in children.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children <18 years old
  • All children undergoing a high digestive endoscopy with per-endoscopic gastric biopsies.
  • Informed consent of parents and children

排除标准

  • Children having received an antibiotic treatment 4 weeks before inclusion
  • Children having received Proton pump inhibitors 2 weeks before inclusion
  • Children having received Bismuth salts 2 weeks before inclusion

结局指标

主要结局

Performance of a new quick, noninvasive, one-step immuno-chromatographic, stool antigen test France) for the detection of H. pylori infection in children

时间窗: Baseline

The performances of the diagnostic test will be assess by considering the reference test as Gold Standard

次要结局

未报告次要终点

研究者

发起方
Lille Catholic University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验