Epidemiology of Helicobacter Pylori Infection in Children... | NCT05846061

Studies
Epidemiology of Helicobacter Pylori Infection in Children From Slovenia

NCT05846061

Sponsor

University Medical Centre Ljubljana

Status

Unknown status

Last Update Posted

May 6, 2023Actual

Enrollment

430Estimated

Phase

Not provided

Conditions

Helicobacter Pylori Infection
Transmission

Interventions

Prevalence study population

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 9, 2021Actual

Primary Completion Date

Jan 9, 2023Actual

Completion Date

Jun 9, 2023Estimated

First Submitted Date

Apr 25, 2023

First Submission Date that Met QC Criteria

Apr 25, 2023

First Posted Date

May 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2023

Last Update Posted Date

May 6, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tadej Battelino, Professor of paediatrics, University Medical Centre LjubljanaPrincipal Investigator

Lead Sponsor

University Medical Centre LjubljanaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

430Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prevalence study population		prevalence study population	Other: Prevalence study population

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prevalence study population	Other	No intervention	Prevalence study population

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of infected children in different age population		3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 6, 14 and 17 years living in three different regions in Slovenia

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

children from school of different age groups- community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Children's Hospital in Ljubljana	Recruiting	Ljubljana		1000	Slovenia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35285106	Background	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.