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

Helicobacter Pylori Infection Clinical Trial

— DISPOSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03324763
• Other study ID #: RT-10
• Status: Completed
• Phase: N/A
• First received: October 25, 2017
• Last updated: October 25, 2017
• Start date: March 19, 2014
• Est. completion date: October 7, 2015

Study information

• Verified date: October 2017
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: October 7, 2015
• Est. primary completion date: October 7, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Other:
• stool sampling
A stool sample will be collected to perform the H. pylori antigen test

Locations

Country	Name	City	State
France	Hôpital Saint Vincent de Paul	Lille	Hauts de France

Sponsors (2)

Lead Sponsor	Collaborator
Lille Catholic University	Hôpital Cochin

Country where clinical trial is conducted

France, 

Outcome

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