The Epidemiology and Etiology of Acute Gastroenteritis Among Estonian Children After Introduction of Rotavirus Vaccines

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

2260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2020-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is designed to estimate the changes in the etiology and epidemiology of acute gastroenteritis in children aged less than 18 years after the implementation of rotavirus vaccine in the Estonian national immunization program in July 2014.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The two-year study period started in February 2015.

The study population consists of all children less than 18-years-old hospitalized due to acute gastroenteritis (AGE) to seven Estonian hospitals participating in this study. Expected sample size is about 2000 patients.

Hospitals that participate in this study are Tartu University Hospital, West-Tallinn Central Hospital, Tallinn's Children Hospital, Pärnu Central Hospital, South-Estonian Hospital, Kuressaare Hospital and Ida-Viru Central Hospital.

Before enrollment all patients are asked to give an informed consent. After enrollment the study doctor completes electronic questionnaire regarding the patients demographic data, medical history and vaccinations. Specific database for our study has been created by company Vision 5D. After completing electronic questionnaire the doctor collects 2 stool samples each 2 ml of volume into Eppendorf tubes produced by our study laboratory. The samples are transported to our study laboratory where they are tested for rotavirus, norovirus G1, G2, astrovirus, adenovirus and sapovirus with Fast-Track Diagnostics real-time assay kit FTD Viral Gastroenteritis. The samples positive for rotavirus are refrigerated at -70 degrees for further genotyping and sequencing.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rotavirus Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

rotavirus, acute gastroenteritis vaccination Estonia impact severity scales

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hospitalized AGE patients

Children less than 18-years-old hospitalized due to acute gastroenteritis to seven Estonian hospitals participating in this study

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* children aged \< 18 year
* hospitalized due to acute gastroenteritis

Exclusion Criteria

* children aged \> 18 years
* gastroenteritis due to known non-infectious causes

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kadri Kõivumägi

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Irja Lutsar, PhD

Role: STUDY_CHAIR

Institute of Microbiology, University of Tartu

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Microbiology, University of Tartu

Tartu, , Estonia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Estonia

References

Explore related publications, articles, or registry entries linked to this study.

Koivumagi K, Soeorg H, Toompere K, Kallas E, Joegeda EL, Lass E, Huik K, Lutsar I; RV Study group. Rotavirus Strain Surveillance in Estonia After Introduction of Rotavirus Universal Mass Vaccination. Pediatr Infect Dis J. 2021 May 1;40(5):489-494. doi: 10.1097/INF.0000000000003039.

Reference Type DERIVED

PMID: 33847298 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

224/T-3

Identifier Type: -

Identifier Source: org_study_id