Performances of a Fast Test for the Detection of Helicobacter Pylori Antigens in Child Stool

Completed

• Conditions: Helicobacter Pylori Infection

• Registration Number: NCT03324763
• Lead Sponsor: Lille Catholic University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-19
• Primary Completion: 2015-10-07
• Study Completion: 2015-10-07
• Status Verified: 2017-10
• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-10-25
• Last Update Submitted: 2017-10-25
• Study First Posted: 2017-10-30
• Last Update Posted: 2017-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance of a new quick, noninvasive, one-step immuno-chromatographic, stool antigen test France) for the detection of H. pylori infection in children	Baseline	The performances of the diagnostic test will be assess by considering the reference test as Gold Standard

Trial Locations

Locations (1)

Hôpital Saint Vincent de Paul; 🇫🇷 Lille, Hauts de France, France