Diagnosing Helicobacter pylori in children using a stool test

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Poitiers University Hospital
  Poitiers, France Recruiting

Study contacts

• Study coordinator: Mailen DAGORRET, MD
• Email: Mailen.DAGORRET@chu-poitiers.fr
• Phone: +33549443389

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.