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

NCT ID: NCT07083804

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 188 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-07
• Study Completion Date: 2028-03-31

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Pediatric patients

Pediatric patients consulted/hospitalized for sampling for the presence or absence of Helicobacter pylori.

Gastric biopsies

Intervention Type: DIAGNOSTIC_TEST

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 sampling

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• 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

• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Poitiers University Hospital

Poitiers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Mailen DAGORRET, MD

Role: CONTACT

Mailen.DAGORRET@chu-poitiers.fr

+33549443389

Celine ABONNEAU, Project manager

Role: CONTACT

celine.abonneau@chu-poitiers.fr

+33516604233

Facility Contacts

Mailen DAGORRET

Role: primary

mailen.dagorret@chu-poitiers.fr

05 49 44 44 44

Other Identifiers

2024-A02366-41

Identifier Type: -

Identifier Source: org_study_id