Performances of a Fast Test for the Detection of Helicobacter Pylori Antigens in Child Stool (DISPOSE)
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|ClinicalTrials.gov Identifier: NCT03324763|
Recruitment Status : Completed
First Posted : October 30, 2017
Last Update Posted : October 30, 2017
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.
|Condition or disease||Intervention/treatment|
|Helicobacter Pylori Infection||Other: stool sampling|
|Study Type :||Observational|
|Actual Enrollment :||158 participants|
|Official Title:||Study of the Performances of a Fast Diagnosis Immunochromatographic Test for the Detection of Helicobacter Pylori (H. Pylori) Antigens in Child Stool|
|Actual Study Start Date :||March 19, 2014|
|Actual Primary Completion Date :||October 7, 2015|
|Actual Study Completion Date :||October 7, 2015|
Other: stool sampling
A stool sample will be collected to perform the H. pylori antigen test
- Performance of a new quick, noninvasive, one-step immuno-chromatographic, stool antigen test France) for the detection of H. pylori infection in children [ Time Frame: Baseline ]The performances of the diagnostic test will be assess by considering the reference test as Gold Standard
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324763
|Hôpital Saint Vincent de Paul|
|Lille, Hauts de France, France, 59000|