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OpenTrials
Completed

NCT Number: NCT03324763

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

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.

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Saint Vincent de Paul

Lille, Hauts-de-France, 59000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stool sampling

Other

A stool sample will be collected to perform the H. pylori antigen test

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Collaborators

  • Hôpital Cochin

Registry information

Official study title

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

Acronym: DISPOSE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 30, 2017
Registry last updated
Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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