- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05846061
Epidemiology of Helicobacter Pylori Infection in Children From Slovenia
April 25, 2023 updated by: Tadej Battelino, University Medical Centre Ljubljana
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
430
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ljubljana, Slovenia, 1000
- Recruiting
- University Children's Hospital in Ljubljana
-
Contact:
- Matjaž Homan, MD PhD
- Phone Number: 0038640885848
- Email: matjaz.homan@guest.arnes.si
-
Contact:
- Nusa Cesar, MD
- Phone Number: 0038615229276
- Email: nusa.cesar@gmai.com
-
Sub-Investigator:
- Polona Maver Vodičar, MD PhD
-
Sub-Investigator:
- Saša Simšič, MD PhD
-
Sub-Investigator:
- Eva Mojškrc, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
children from school of different age groups- community sample
Description
Inclusion Criteria:
- age 6, 14 and 17 years living in three different regions in Slovenia
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Prevalence study population
prevalence study population
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The number of infected children in different age population
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 9, 2021
Primary Completion (Actual)
January 9, 2023
Study Completion (Anticipated)
June 9, 2023
Study Registration Dates
First Submitted
April 25, 2023
First Submitted That Met QC Criteria
April 25, 2023
First Posted (Estimate)
May 5, 2023
Study Record Updates
Last Update Posted (Estimate)
May 5, 2023
Last Update Submitted That Met QC Criteria
April 25, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07011968
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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