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

NCT03324763 | Completed

• 1 other identifier: RT-10
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

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

  The performances of the diagnostic test will be assess by considering the reference test as Gold Standard

  Baseline

Study Arms (1)

stool sampling

Other: stool sampling

Interventions

stool sampling OTHER

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

stool sampling

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Lille Catholic University: lead
• Hôpital Cochin: collaborator

Study Sites (1)

Hôpital Saint Vincent de Paul

Lille, Hauts-de-France, 59000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool of children

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 30, 2017
• Study Start: March 19, 2014
• Primary Completion: October 7, 2015
• Study Completion: October 7, 2015
• Last Updated: October 30, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)