Feasibility Study to Diagnose Helicobacter Pylori in Children Using Non-Invasive Stool Analysis

What this Trial Is About

Helicobacter pylori infection is a common bacterial disease affecting nearly half of the global population, with distinct characteristics in children compared to adults. Children usually acquire the infection early in life, often linked to socio-economic factors, and while many show no symptoms, some experience digestive issues. This infection can lead to serious stomach changes and increase cancer risk later, highlighting the need for reliable, non-invasive diagnostic tests in children. Researchers are evaluating a stool-based PCR test for detecting H. pylori and antibiotic resistance, comparing it to traditional gastric biopsy methods in children. The study involves pediatric patients who are undergoing gastroscopy with gastric biopsies for various digestive symptoms or conditions. Stool samples are collected within 10 days of the endoscopy and analyzed using antigen and molecular techniques to detect H. pylori and clarithromycin resistance mutations. This observational study compares the diagnostic accuracy of the stool PCR test to the standard biopsy results, aiming to assess its sensitivity, specificity, and predictive values. Participants will provide stool samples following their routine endoscopy procedures, with researchers monitoring the accuracy and reliability of the PCR method. The study measures include diagnostic performance of stool PCR for H. pylori and resistance detection, adherence to stool self-sampling, and antibiotic resistance profiles. The total involvement duration for outcome measurement is about 10 days after stool collection. The study is sponsored by Poitiers University Hospital and runs until March 2028.

Feasibility Study to Diagnose Helicobacter Pylori in the Paediatric Population Using Non-invasive Fecal Analysis