HELICOBACTER PYLORI INFECTIONSHEPYCANCT07083804
Feasibility Study to Diagnose Helicobacter Pylori in the Paediatric Population Using Non-invasive Fecal Analysis
An observational study of HELICOBACTER PYLORI INFECTIONS, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- What is being tested?
- Gastric biopsies and Stool sampling
- How many people
- 188 participants
- Where
- 1 siteFrance
- Study dates
- 7 Oct 2025to Mar 2028
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children requiring gastric biopsies for H. pylori detection
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Poitiers University Hospital
Poitiers
Mailen DAGORRET, 05 49 44 44 44, mailen.dagorret@chu-poitiers.fr
About this study
Official title: Feasibility Study to Diagnose Helicobacter Pylori In The Paediatric Population Using Non-Invasive Fecal Analysis: the HEPYCA Study
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
- Being tested
- Gastric biopsies, Stool sampling
- Keywords
- Pediatrics, Gastroenterology, Microbiology, Infectious disease, Helicobacter pylori
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric biopsiesDiagnostic 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 samplingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients | Pediatric patients consulted/hospitalized for sampling for the presence or absence of Helicobacter pylori. Receives: Diagnostic Test: Gastric biopsies; Diagnostic Test: Stool sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 days
Secondary outcomes (9)
Evaluate the intrinsic diagnostic performance (Se, Sp) of H. pylori PCR in stools
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).
Measured: 10 days
Evaluate the extrinsic diagnostic performance (PPV, NPV) of H. pylori PCR in stools
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).
Measured: 10 days
Evaluate the intrinsic diagnostic performance (Se, Sp) of clarithromycin-resistant H. pylori PCR in stools
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).
Measured: 10 days
Evaluate the extrinsic diagnostic performance (PPV, NPV) of clarithromycin-resistant H. pylori PCR in stools
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).
Measured: 10 days
Evaluate the intrinsic and extrinsic diagnostic performance of H. pylori PCR and H. pylori antigen in stools
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).
Measured: 10 days
Evaluate the intrinsic diagnostic performance (Se, Sp) of H. pylori PCR in stools
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.
Measured: 10 days
Evaluate the extrinsic diagnostic performance (PPV, NPV) of H. pylori PCR in stool
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.
Measured: 10 days
Evaluate the adherence of a stool self-sampling for H. pylori
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
Measured: 10 days
Analyze resistance profiles to the various antibiotics used in Helicobacter pylori eradication therapy
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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start7 Oct 2025
- Primary completionOct 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 188 participants (estimated)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083804
- Sponsor's protocol ID
- 2024-A02366-41
- Acronym
- HEPYCA
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Diagnose Helicobacter Pylori In The Paediatric Population Using Non-Invasive Fecal Analysis: the HEPYCA Study
- ClinicalTrials.gov ID
- NCT07083804
- Acronym / sponsor ID
- HEPYCA / 2024-A02366-41
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Keywords
- Pediatrics, Gastroenterology, Microbiology, Infectious disease, Helicobacter pylori
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients | – | Diagnostic Test: Gastric biopsies, Diagnostic Test: Stool samplingPediatric patients consulted/hospitalized for sampling for the presence or absence of Helicobacter pylori. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children requiring gastric biopsies for H. pylori detection
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric biopsiesAfter obtaining informed consent, patients receive routine endoscopic procedures with an additional biopsy taken for research purposes. Invasive screening method used in routine care. | Diagnostic test | Pediatric patients |
| Stool samplingStool 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. | Diagnostic test | Pediatric patients |
Primary outcome
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).
9 secondary outcomes
Evaluate the intrinsic diagnostic performance (Se, Sp) of H. pylori PCR in stools
Time frame: 10 days
Evaluate the extrinsic diagnostic performance (PPV, NPV) of H. pylori PCR in stools
Time frame: 10 days
Evaluate the intrinsic diagnostic performance (Se, Sp) of clarithromycin-resistant H. pylori PCR in stools
Time frame: 10 days
Evaluate the extrinsic diagnostic performance (PPV, NPV) of clarithromycin-resistant H. pylori PCR in stools
Time frame: 10 days
Evaluate the intrinsic and extrinsic diagnostic performance of H. pylori PCR and H. pylori antigen in stools
Time frame: 10 days
Evaluate the intrinsic diagnostic performance (Se, Sp) of H. pylori PCR in stools
Time frame: 10 days
Evaluate the extrinsic diagnostic performance (PPV, NPV) of H. pylori PCR in stool
Time frame: 10 days
Evaluate the adherence of a stool self-sampling for H. pylori
Time frame: 10 days
Analyze resistance profiles to the various antibiotics used in Helicobacter pylori eradication therapy
Time frame: 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HELICOBACTER PYLORI INFECTIONS, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mailen DAGORRET, MD (+33549443389, Mailen.DAGORRET@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the diagnostic performance of H. pylori PCR in stools (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.