Helicobacter Pylori InfectionGFHPPNCT03541876
French Pediatric Helicobacter Pylori Observatory
An observational study of Helicobacter Pylori Infection, run by Lille Catholic University at 1 site in France.
Trial summary
Helicobacter pylori is a major human pathogen associated with significant morbidity. The treatment oriented by the antibiogram or PCR (Polymerase Chain Reaction) should be privileged in children. However, the optimal treatment for the eradication of pediatric H. pylori infection is still not established. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Collection of data
- How many people
- 1,201 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2018to Feb 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with confirmed diagnosis of H. pylori infection
Who may be able to join
- Child with confirmed H. pylori infection by direct diagnostic methods after periendoscopic gastric biopsies
- Age < 18
- No opposition of at least one of the 2 parents to the use of health data for research purposes
Who cannot join
- Child with confirmed H. pylori infection by indirect diagnostic methods
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Data Collection for the Creation of the French Pediatric Helicobacter Pylori Observatory
Helicobacter pylori is a major human pathogen associated with significant morbidity. The treatment oriented by the antibiogram or PCR (Polymerase Chain Reaction) should be privileged in children. However, the optimal treatment for the eradication of pediatric H. pylori infection is still not established.
No French consensus conference on the management of H. pylori infection in children taking into account the epidemiological data available for this infection has been published. The description of diagnostic and therapeutic management procedures has not yet been specifically described according to the country of birth of children. The main objective is to collect data enabling the establishment of a French observatory of Helicobacter pylori in children in order to provide a national database.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Collection of data
- Keywords
- children, treatment, observatory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of dataOther
The following data will be collected by the physician :
sociodemographic profile (age, sex, country of birth of child and parents); clinical manifestations; endoscopic aspects (esophagus, duodenum, stomach); different methods of diagnosis of infection; different primary and secondary bacterial resistance profiles ; different first and second line therapeutic combinations; different first and second line bacterial eradication rates ; different signs of side effects and tolerance of first and second line treatments; different methods of bacterial eradication control.
| Study group | Role | What they receive |
|---|---|---|
| children with H. pylori infection | Not described Receives: Other: Collection of data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of H. pylori infection
Child with confirmed H. pylori infection by direct diagnostic methods (Histology, Bacterial culture, PCR) on perendoscopic gastric biopsies
Measured: at inclusion
Age
Measured: at inclusion
Sex
Measured: at inclusion
Country of birth
Measured: at inclusion
Clinical symptoms
Measured: at inclusion, 3 and 6 months
Microbiological diagnosis
Measured: at inclusion, 3 and 6 months
Endoscopic diagnosis
Measured: at inclusion, 3 and 6 months
Rates of bacterial resistance profiles
Measured: at inclusion, at 3 and 6 months
antibiotic therapy
Measured: at inclusion, 3 and 6 months
Bacterial eradication rates
Measured: 3 and 6 months
Side effects and tolerance of first and second line treatments
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start9 Jan 2018
- Primary completion1 Feb 2022
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,201 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Kalach, PR, Principal investigator, Lille Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541876
- Sponsor's protocol ID
- RC-P0058
- Acronym
- GFHPP
- Status last verified
- Jun 2023
- First submitted
- 23 Apr 2018
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection for the Creation of the French Pediatric Helicobacter Pylori Observatory
- ClinicalTrials.gov ID
- NCT03541876
- Acronym / sponsor ID
- GFHPP / RC-P0058
- Conditions
- Helicobacter Pylori Infection
- Keywords
- children, treatment, observatory
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,201 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- Feb 2024 (estimated)
- First posted
- 31 May 2018 (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 is a major human pathogen associated with significant morbidity. The treatment oriented by the antibiogram or PCR (Polymerase Chain Reaction) should be privileged in children. However, the optimal treatment for the eradication of pediatric H. pylori infection is still not established.
No French consensus conference on the management of H. pylori infection in children taking into account the epidemiological data available for this infection has been published. The description of diagnostic and therapeutic management procedures has not yet been specifically described according to the country of birth of children. The main objective is to collect data enabling the establishment of a French observatory of Helicobacter pylori in children in order to provide a national database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children with H. pylori infection | – | Other: Collection of data |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with confirmed diagnosis of H. pylori infection
Key inclusion criteria (3 listed)
- Child with confirmed H. pylori infection by direct diagnostic methods after periendoscopic gastric biopsies
- Age < 18
- No opposition of at least one of the 2 parents to the use of health data for research purposes
Key exclusion criteria (1 listed)
- Child with confirmed H. pylori infection by indirect diagnostic methods
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 |
|---|---|---|
| Collection of dataThe following data will be collected by the physician : sociodemographic profile (age, sex, country of birth of child and parents); clinical manifestations; endoscopic aspects (esophagus, duodenum, stomach); different methods of diagnosis of infection; different primary and secondary bacterial resistance profiles ; different first and second line therapeutic combinations; different first and second line bacterial eradication rates ; different signs of side effects and tolerance of first and second line treatments; different methods of bacterial eradication control. | Other | children with H. pylori infection |
Primary outcome
Diagnosis of H. pylori infection
Time frame: at inclusion
Child with confirmed H. pylori infection by direct diagnostic methods (Histology, Bacterial culture, PCR) on perendoscopic gastric biopsies
Age
Time frame: at inclusion
Sex
Time frame: at inclusion
Country of birth
Time frame: at inclusion
Clinical symptoms
Time frame: at inclusion, 3 and 6 months
Microbiological diagnosis
Time frame: at inclusion, 3 and 6 months
Endoscopic diagnosis
Time frame: at inclusion, 3 and 6 months
Rates of bacterial resistance profiles
Time frame: at inclusion, at 3 and 6 months
antibiotic therapy
Time frame: at inclusion, 3 and 6 months
Bacterial eradication rates
Time frame: 3 and 6 months
Side effects and tolerance of first and second line treatments
Time frame: 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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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. This study is not recruiting at the moment.
Nicolas Kalach, PR principal investigator
Lille Catholic University
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 Infection, run by Lille Catholic University 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of H. pylori infection (time frame: at inclusion). The study lists 11 primary outcomes in all. 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 22 Jun 2023.