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

NCT07083804 | Recruiting

• 1 other identifier: 2024-A02366-41
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

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

Keywords

Pediatrics; Gastroenterology; Microbiology; Infectious disease; Helicobacter pylori

Outcome Measures

Primary Outcomes (1)

• Evaluate 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).

  10 days

Secondary Outcomes (9)

• Evaluate the intrinsic diagnostic performance (Se, Sp) of H. pylori PCR in stools

  10 days

• Evaluate the extrinsic diagnostic performance (PPV, NPV) of H. pylori PCR in stools

  10 days

• Evaluate the intrinsic diagnostic performance (Se, Sp) of clarithromycin-resistant H. pylori PCR in stools

  10 days

• Evaluate the extrinsic diagnostic performance (PPV, NPV) of clarithromycin-resistant H. pylori PCR in stools

  10 days

• Evaluate the intrinsic and extrinsic diagnostic performance of H. pylori PCR and H. pylori antigen in stools

  10 days

Study Arms (1)

Pediatric patients

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

Diagnostic Test: Gastric biopsies; Diagnostic Test: Stool sampling

Interventions

Gastric biopsies 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.

Pediatric patients

Stool sampling 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.

Pediatric patients

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children requiring gastric biopsies for H. pylori detection

You may qualify if:

• 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.

You may not qualify if:

• Failure to send/receive stool sample
• Biopsy not performed at endoscopy

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Poitiers University Hospital

Poitiers, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gastric biopsy and stool

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mailen DAGORRET, MD

CONTACT

+33549443389; Mailen.DAGORRET@chu-poitiers.fr

Celine ABONNEAU, Project manager

CONTACT

+33516604233; celine.abonneau@chu-poitiers.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 24, 2025
• Study Start: October 7, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: November 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)