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

Study of the Performances of a Fast Diagnosis Immunochromatographic Test for the Detection of Helicobacter Pylori (H. 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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Other: stool sampling

• Study Type: Observational
• Enrollment (Actual): 158

Contacts and Locations

Study Locations

• France
  • Hauts de France
    • Lille, Hauts de France, France, 59000
      • Hôpital Saint Vincent de Paul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with various digestive symptoms suggesting upper gastrointestinal tract disease consulting at Saint Antoine paediatric clinic, Saint Vincent de Paul Hospital, Lille-France.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
stool sampling	Other: stool sampling; A stool sample will be collected to perform the H. pylori antigen test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Collaborators: Hôpital Cochin

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2014
• Primary Completion (Actual): October 7, 2015
• Study Completion (Actual): October 7, 2015

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): October 30, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: RT-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No