Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03324763
Recruitment Status : Completed
First Posted : October 30, 2017
Last Update Posted : October 30, 2017
Sponsor:
Collaborator:
Hôpital Cochin
Information provided by (Responsible Party):
Lille Catholic University

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.


Condition or disease Intervention/treatment
Helicobacter Pylori Infection Other: stool sampling

Layout table for study information
Study Type : Observational
Actual Enrollment : 158 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Performances of a Fast Diagnosis Immunochromatographic Test for the Detection of Helicobacter Pylori (H. Pylori) Antigens in Child Stool
Actual Study Start Date : March 19, 2014
Actual Primary Completion Date : October 7, 2015
Actual Study Completion Date : October 7, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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




Primary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Stool of children


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324763


Locations
Layout table for location information
France
Hôpital Saint Vincent de Paul
Lille, Hauts de France, France, 59000
Sponsors and Collaborators
Lille Catholic University
Hôpital Cochin

Layout table for additonal information
Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT03324763     History of Changes
Other Study ID Numbers: RT-10
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No