Prevalence of Symptomatic Gastroesophageal Reflux Disease in Czech Children (Czech GERDKids)

NCT07482969 | Recruiting

• 2 other identifiers: GERD-CZ-2025NW25J-09-00146
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the prevalence of symptomatic gastroesophageal reflux disease (GERD) in children aged 8-9 years and 12-13 years in the Czech Republic. Participants are recruited through schools and complete a web-based questionnaire assessing reflux-related symptoms. Children reporting pyrosis or regurgitation undergo a stepwise diagnostic evaluation that includes a standardized proton pump inhibitor (PPI) trial, upper endoscopy when indicated, and 24-hour pH-impedance monitoring for those with inconclusive findings. These procedures allow classification into confirmed GERD, reflux hypersensitivity, or functional pyrosis. All children undergoing diagnostic testing complete a validated quality-of-life questionnaire. The study will provide population-based prevalence estimates and evaluate symptom burden and potential risk factors associated with pediatric GERD.

Conditions

Gastro Esophageal Reflux

Keywords

Reflux disease; Children; Prevalence; Population

Outcome Measures

Primary Outcomes (1)

• Number of participants with Gastroesophageal Reflux Disease by Lyon consensus

  Symptomatic GERD, defined as the presence of pyrosis or regurgitation with a positive PPI diagnostic test and/or consistent findings on endoscopic examination and/or a reflux index (RI) above 6% on pHmetric and impedance examination. Detailed definition of GERD (according to the Lyon Consensus): 1. Clinical definition: positive clinical response, defined as a significant difference (decrease) in the intensity of clinical complaints recorded daily for 42 days before and during 42 days of PPIs use at an adequate dose of 2 mg/kg/day 2. Endoscopical definition: reflux esophagitis according to Los Angeles classification grade 3 and 4, stricture, Barrett's oesophagus 3. Functional examination with pHmetry with impedance (pHmetry/MII): reflux index above 6%

  Day 1

Secondary Outcomes (2)

• Number of participants with Functional pyrosis and Reflux hypersensitivity by Lyon consensus

  Day 1

• Quality of life of patients with confirmed GERD, functional pyrosis or reflux hypersensitivity

  Day 1

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited through a nationwide network of primary schools using voluntary participation after parental consent. The sample is designed to approximate a representative cross-section of Czech children aged 8-9 and 12-13 years but is based on non-probability sampling.

You may qualify if:

• age group of 8 - 9 years and 12 - 13 years
• school attendance ability

You may not qualify if:

• psychomotor impairment

Sponsors & Collaborators

• University Hospital, Motol: lead

Study Sites (1)

Motol University Hospital

Prague, Czechia

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Tereza Lerchova

CONTACT

+420775201573; terezadrskova@gmail.com

Jana Duskova

CONTACT

+420733257719; jancapavelcova@seznam.cz

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: March 19, 2026
• Study Start: December 20, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 19, 2026

Record last verified: 2025-12

Locations

CZ (1)