Helicobacter Pylori InfectionNCT05846061
Epidemiology of Helicobacter Pylori Infection in Children From Slovenia
An observational study of Helicobacter Pylori Infection and Transmission, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The epidemiology of H. pylori infection among children in Slovenia has not been investigated. Therefore, we are conducting a study to examine the epidemiology of H. pylori and associated risk factors among children in Slovenia. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection, Transmission
- What is being tested?
- Prevalence study population
- How many people
- 430 participants
- Where
- 1 siteSlovenia
- Study dates
- 9 Jan 2021to 9 Jun 2023
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: children from school of different age groups- community sample
Who may be able to join
- age 6, 14 and 17 years living in three different regions in Slovenia
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University Children's Hospital in Ljubljana
Ljubljana, 1000
Matjaz Homan, MD PhD, 0038640885848, matjaz.homan@guest.arnes.si
Nusa Cesar, MD, 0038615229276, nusa.cesar@gmai.com
About this study
The epidemiology of H. pylori infection among children in Slovenia has not been investigated. Therefore, we are conducting a study to examine the epidemiology of H. pylori and associated risk factors among children in Slovenia.
Read the detailed description
The population selection was from the three different geographic location in Slovenia. The selection of the studied places was based on their social and economic characteristics and medical provision. We included children from three age groups at the same time we collected information from the parents which may be important for H. pylori transmission.
- Conditions
- Helicobacter Pylori Infection, Transmission
- Being tested
- Prevalence study population
- Keywords
- children, infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevalence study populationOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Prevalence study population | prevalence study population Receives: Other: Prevalence study population |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of infected children in different age population
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start9 Jan 2021
- Primary completion9 Jan 2023
- Study completion9 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tadej Battelino, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846061
- Sponsor's protocol ID
- 07011968
- Status last verified
- Apr 2023
- First submitted
- 25 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Polivanova TV, Malaty H, Vshivkov VA. Epidemiology Helicobacter pylori infection in children in the Tyva Republic (Russia). Helicobacter. 2022 Jun;27(3):e12882. doi: 10.1111/hel.12882. Epub 2022 Mar 13.
PubMed 35285106
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Helicobacter Pylori Infection in Children From Slovenia
- ClinicalTrials.gov ID
- NCT05846061
- Acronym / sponsor ID
- 07011968
- Conditions
- Helicobacter Pylori Infection, Transmission
- Keywords
- children, infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 9 Jan 2021 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 9 Jun 2023 (estimated)
- First posted
- 6 May 2023 (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.
The epidemiology of H. pylori infection among children in Slovenia has not been investigated. Therefore, we are conducting a study to examine the epidemiology of H. pylori and associated risk factors among children in Slovenia.
Detailed description
The population selection was from the three different geographic location in Slovenia. The selection of the studied places was based on their social and economic characteristics and medical provision. We included children from three age groups at the same time we collected information from the parents which may be important for H. pylori transmission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevalence study population | – | Other: Prevalence study populationprevalence study population |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- children from school of different age groups- community sample
Key inclusion criteria (1 listed)
- age 6, 14 and 17 years living in three different regions in Slovenia
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Prevalence study populationNo intervention | Other | Prevalence study population |
Primary outcome
The number of infected children in different age population
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 35285106Polivanova TV, Malaty H, Vshivkov VA. Epidemiology Helicobacter pylori infection in children in the Tyva Republic (Russia). Helicobacter. 2022 Jun;27(3):e12882. doi: 10.1111/hel.12882. Epub 2022 Mar 13.
- 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. This study is not recruiting at the moment.
University Children's Hospital in Ljubljana
Ljubljana, Slovenia
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 and Transmission, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 1 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 6 May 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 Slovenia. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of infected children in different age population (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05846061, which also lists 1 linked publication.
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 6 May 2023.