Helicobacter pylori infection is a widespread bacterial disease affecting nearly half of the world's population. In children, the infection displays distinct features versus adults, with lower prevalence, variable symptoms, and differing endoscopic and histological appearances. Typically acquired in early childhood, its transmission is closely linked to socio-economic disadvantage and overcrowding. Although most infected children are asymptomatic, some develop epigastric pain, dyspepsia, weight loss, or other gastrointestinal disturbances. Chronic infection may eventually lead to mucosal atrophy and intestinal metaplasia, increasing the risk of gastric cancer later in life. Given the limitations and risks of invasive diagnostic methods-especially endoscopy under general anesthesia-there is a critical need for reliable, non-invasive tests. Recent adult studies indicate that stool-based PCR is a promising alternative for both detecting H. pylori and identifying clarithromycin resistance. The primary objectives of this study are to evaluate the intrinsic diagnostic performance of high-resolution melt PCR (HP PCR) in stools, and to compare these results with those obtained from a conventional work-up, such as gastric biopsies, in a paediatric population. In accordance with prevailing rationality, the principal outcome of this study will be an evaluation of the intrinsic diagnostic capabilities of the proposed method. This will be accomplished by conducting a comparison of the sensitivity and specificity of the PCR test in stools with those of gastric biopsies (reference test).
Study Type
OBSERVATIONAL
Enrollment
188
After obtaining informed consent, patients receive routine endoscopic procedures with an additional biopsy taken for research purposes. Invasive screening method used in routine care.
Stool samples are taken and sent within 10 days of the endoscopy. Self-collected stool samples are analyzed using antigen testing and molecular techniques to detect H. pylori and associated resistance mutations. Experimental diagnosis.
Poitiers University Hospital
Poitiers, France
RECRUITINGEvaluate the diagnostic performance of H. pylori PCR in stools
Diagnostic capabilities will be assessed by the error rate (false positives and negatives) of the stool PCR test, compared with the results of PCR biopsy (reference test).
Time frame: 10 days
Evaluate the intrinsic diagnostic performance (Se, Sp) of H. pylori PCR in stools
Intrinsic diagnostic capabilities will be assessed by comparing the sensitivity and specificity of the stool PCR test with the results of gastric biopsies (reference test).
Time frame: 10 days
Evaluate the extrinsic diagnostic performance (PPV, NPV) of H. pylori PCR in stools
Extrinsic diagnostic capabilities will be assessed by comparing the positive and negative predictive values of the stool PCR test with the results of gastric biopsies (reference test).
Time frame: 10 days
Evaluate the intrinsic diagnostic performance (Se, Sp) of clarithromycin-resistant H. pylori PCR in stools
Intrinsic diagnostic capabilities will be assessed by comparing the sensitivity, specificity and positive and negative predictive values of the clarithromycin-resistant H. pylori PCR test in stools with those of gastric biopsies (reference test).
Time frame: 10 days
Evaluate the extrinsic diagnostic performance (PPV, NPV) of clarithromycin-resistant H. pylori PCR in stools
Extrinsic diagnostic capabilities will be assessed by comparing the sensitivity and specificity, as well as the positive and negative predictive values, of the clarithromycin-resistant H. pylori PCR test in stools with the results of gastric biopsies (reference test).
Time frame: 10 days
Evaluate the intrinsic and extrinsic diagnostic performance of H. pylori PCR and H. pylori antigen in stools
Intrinsic and extrinsic diagnostic capabilities will be assessed by comparing the sensitivity and specificity and positive and negative predictive values of the stool antigen test with the results of gastric biopsies (reference test).
Time frame: 10 days
Evaluate the intrinsic diagnostic performance (Se, Sp) of H. pylori PCR in stools
Intrinsic diagnostic capabilities will be assessed by the sensitivity and specificity and positive and negative predictive values of the stool PCR test, and compared with stool antigen results.
Time frame: 10 days
Evaluate the extrinsic diagnostic performance (PPV, NPV) of H. pylori PCR in stool
Extrinsic diagnostic capabilities will be assessed by the sensitivity and specificity and positive and negative predictive values of the stool PCR test, and compared with stool antigen results.
Time frame: 10 days
Evaluate the adherence of a stool self-sampling for H. pylori
Adherence to stool sampling will be assessed by the number of stool samples received in the population analyzed out of the number of patients included
Time frame: 10 days
Analyze resistance profiles to the various antibiotics used in Helicobacter pylori eradication therapy
Analyze resistance profiles to the various antibiotics used in Helicobacter pylori eradication therapy in relation to biological test results (PCR in biopsy and stool, stool antigens) and clinical presentation. Resistance profiles will be expressed in micrograms per mL and interpreted in accordance with the current guidelines of the Antibiogram Committee of the French Microbiology Society.
Time frame: 10 days
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