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NCT Number: NCT07083804

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

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).

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Key information

Conditions

HELICOBACTER PYLORI INFECTIONS Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Evaluate the diagnostic performance of H. pylori PCR in stools

    Time frame: 10 days

    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).

Secondary outcomes

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

    Time frame: 10 days

    Intrinsic diagnostic capabilities will be assessed by comparing the sensitivity and specificity of the stool PCR test with the results of gastric biopsies (reference test).

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

    Time frame: 10 days

    Extrinsic diagnostic capabilities will be assessed by comparing the positive and negative predictive values of the stool PCR test with the results of gastric biopsies (reference test).

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

    Time frame: 10 days

    Intrinsic diagnostic capabilities will be assessed by comparing the sensitivity, specificity and positive and negative predictive values of the clarithromycin-resistant H. pylori PCR test in stools with those of gastric biopsies (reference test).

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

    Time frame: 10 days

    Extrinsic diagnostic capabilities will be assessed by comparing the sensitivity and specificity, as well as the positive and negative predictive values, of the clarithromycin-resistant H. pylori PCR test in stools with the results of gastric biopsies (reference test).

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

    Time frame: 10 days

    Intrinsic and extrinsic diagnostic capabilities will be assessed by comparing the sensitivity and specificity and positive and negative predictive values of the stool antigen test with the results of gastric biopsies (reference test).

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

    Time frame: 10 days

    Intrinsic diagnostic capabilities will be assessed by the sensitivity and specificity and positive and negative predictive values of the stool PCR test, and compared with stool antigen results.

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

    Time frame: 10 days

    Extrinsic diagnostic capabilities will be assessed by the sensitivity and specificity and positive and negative predictive values of the stool PCR test, and compared with stool antigen results.

  8. Evaluate the adherence of a stool self-sampling for H. pylori

    Time frame: 10 days

    Adherence to stool sampling will be assessed by the number of stool samples received in the population analyzed out of the number of patients included

  9. Analyze resistance profiles to the various antibiotics used in Helicobacter pylori eradication therapy

    Time frame: 10 days

    Analyze resistance profiles to the various antibiotics used in Helicobacter pylori eradication therapy in relation to biological test results (PCR in biopsy and stool, stool antigens) and clinical presentation. Resistance profiles will be expressed in micrograms per mL and interpreted in accordance with the current guidelines of the Antibiogram Committee of the French Microbiology Society.

Study contacts

Contact information is provided by the study sponsor or research team.

Celine ABONNEAU, Project manager

CONTACT

[email protected]

+33516604233

Mailen DAGORRET, MD

CONTACT

[email protected]

+33549443389

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

Feasibility Study to Diagnose Helicobacter Pylori In The Paediatric Population Using Non-Invasive Fecal Analysis: the HEPYCA Study

Acronym: HEPYCA

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 24, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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