Diagnosing Helicobacter pylori in children using a stool test
Feasibility Study to Diagnose Helicobacter Pylori In The Paediatric Population Using Non-Invasive Fecal Analysis: the HEPYCA Study
Poitiers University Hospital · NCT07083804
This project will test whether a stool-based PCR can detect Helicobacter pylori and identify clarithromycin resistance in children who are having gastroscopy with biopsies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 188 (estimated) |
| Ages | N/A to 16 Years |
| Sex | All |
| Sponsor | Poitiers University Hospital (other) |
| Locations | 1 site (Poitiers) |
| Trial ID | NCT07083804 on ClinicalTrials.gov |
What this trial studies
This observational feasibility study will compare non-invasive stool PCR results to gastric biopsy findings obtained during routine pediatric gastroscopy. Stool samples will be collected and analyzed for H. pylori presence and clarithromycin resistance markers, and results will be compared with endoscopic biopsy plus histology/microbiology. The target population is children up to 16 years old who have a clinical indication for gastroscopy and whose parents provide consent. The work builds on promising adult data and aims to determine whether stool-based testing can reliably replace or reduce invasive diagnostic procedures in children.
Who should consider this trial
Good fit: Children aged 16 years or younger who are already scheduled for diagnostic gastroscopy with gastric biopsies and whose legal guardians consent (and who provide assent when appropriate).
Not a fit: Children recently treated with antibiotics or on recent proton pump inhibitor therapy, those with contraindications to endoscopy, or those unable to provide a stool sample may not benefit because results can be unreliable or the protocol cannot be completed.
Why it matters
Potential benefit: If successful, the test could allow diagnosis and antibiotic-resistance detection without invasive endoscopy and general anesthesia, lowering procedure risk and burden for children.
How similar studies have performed: Stool-based PCR has shown good detection and resistance-typing performance in adults, but pediatric evidence is limited and this is a feasibility effort in children.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \< or = 16 years ; * Any indication for gastroscopy in children requiring gastric biopsies: gastro-esophageal reflux resistant to proton pump inhibitors (PPIs) or recurrent on discontinuation of PPIs, hematemesis, refractory anemia or unexplained inflammatory syndrome, recurrent vomiting, dysphagia, endoscopic assessment of chronic inflammatory bowel disease with search for H. pylori superinfection ; * Patients benefiting from a Social Security scheme or benefiting from one via a third part; * Holders of parental authority who have given their informed consent to participate in the study and child participants of understanding age who have given their assent. Non-inclusion Criteria: * Antibiotic treatment less than 4 weeks * PPIs treatment less than 2 weeks * Contraindication to endoscopic procedure or biopsy. Exclusion Criteria: * Antibiotic therapy prior to stool collection (between inclusion and stool collection, which may be 10 days later) * Failure to send/receive stool sample * Biopsy not performed at endoscopy
Where this trial is running
Poitiers
- Poitiers University Hospital — Poitiers, France (RECRUITING)
Study contacts
- Study coordinator: Mailen DAGORRET, MD
- Email: Mailen.DAGORRET@chu-poitiers.fr
- Phone: +33549443389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HELICOBACTER PYLORI INFECTIONS, Pediatrics, Gastroenterology, Microbiology, Infectious disease, Helicobacter pylori