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

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Number of participants with Gastroesophageal Reflux Disease by Lyon consensus — Day 1
  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%

Trial sites (1)

More University Hospital, Motol trials in Czechia