NCT05846061

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
430

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2023

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

April 25, 2023

Last Update Submit

April 25, 2023

Conditions

Helicobacter Pylori InfectionTransmission

Keywords

childreninfection

Outcome Measures

Primary Outcomes (1)

  • The number of infected children in different age population

    3 years

Study Arms (1)

Prevalence study population

prevalence study population

Other: Prevalence study population

Interventions

Prevalence study populationOTHER

No intervention

Prevalence study population

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children from school of different age groups- community sample

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital in Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35285106BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

stool specimens

MeSH Terms

Conditions

Infections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of paediatrics

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 6, 2023

Study Start

January 9, 2021

Primary Completion

January 9, 2023

Study Completion

June 9, 2023

Last Updated

May 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)