How common symptomatic gastroesophageal reflux is in Czech children aged 8–9 and 12–13
Prevalence of Symptomatic Gastroesophageal Reflux Disease in Children in the Czech Republic
This project will see how common symptomatic GERD is in Czech children aged 8–9 and 12–13 by using school questionnaires and follow-up medical testing for kids who report reflux symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 8 Years to 13 Years |
| Sex | All |
| Sponsor | University Hospital, Motol Academic / other |
| Locations | 1 site (Prague) |
| Trial ID | NCT07482969 on ClinicalTrials.gov |
What this trial studies
This population-based, cross-sectional study recruits children aged 8–9 and 12–13 through selected schools in the Czech Republic and begins with a secure web-based questionnaire about reflux symptoms and related factors. Children reporting heartburn (pyrosis) or regurgitation enter a stepwise diagnostic pathway starting with a standardized 14-day proton pump inhibitor (PPI) trial including 14 days of baseline symptom recording and 14 days on PPI at age-appropriate doses. Those without a clear response undergo upper endoscopy to look for esophagitis or complications, and if endoscopy is normal or inconclusive they receive 24-hour pH-impedance monitoring to quantify reflux and symptom association. Final classifications (confirmed GERD, reflux hypersensitivity, or functional pyrosis) are combined with validated quality-of-life measures to produce population prevalence estimates and explore symptom burden and risk factors.
Who should consider this trial
Good fit: Children aged 8–9 or 12–13 who attend participating schools in the Czech Republic and can complete the web questionnaire and diagnostic testing, and who do not have psychomotor impairment, are the intended participants.
Not a fit: Children who are asymptomatic, live outside the Czech Republic, cannot travel to Prague for diagnostic testing, or have psychomotor impairment are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could clarify how many children have true GERD versus other causes of reflux symptoms, helping doctors target treatment and avoid unnecessary long-term PPI use.
How similar studies have performed: Similar population-based questionnaires combined with guideline-based diagnostic pathways have been used in other pediatric populations and produced credible prevalence data, so the approach is well-established though country-specific data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age group of 8 - 9 years and 12 - 13 years * school attendance ability Exclusion Criteria: * psychomotor impairment
Where this trial is running
Prague
- Motol University Hospital — Prague, Czechia (Recruiting)
Study contacts
- Study coordinator: Tereza Lerchova
- Email: terezadrskova@gmail.com
- Phone: +420775201573
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.