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

Lille Catholic University

Status: Completed

Conditions: Helicobacter Pylori Infection

Treatments: Other: stool sampling

Study type: Observational

Funder types: Other

Identifiers

NCT03324763

RT-10

Details and patient eligibility

About

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.

Enrollment: 158 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

158 participants in 1 patient group

stool sampling

Treatment:

Other: stool sampling