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

NCT07083804 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 188

Last updated 2025-11-20

No results posted yet for this study

Summary

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).

Conditions

  • HELICOBACTER PYLORI INFECTIONS

Interventions

DIAGNOSTIC_TEST

Gastric biopsies

After obtaining informed consent, patients receive routine endoscopic procedures with an additional biopsy taken for research purposes. Invasive screening method used in routine care.

DIAGNOSTIC_TEST

Stool sampling

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.

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Eligibility

Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-07
Primary Completion
2027-10-31
Completion
2028-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07083804 on ClinicalTrials.gov