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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-13
SponsorUniversity Hospital, Motol

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

age group of 8 - 9 years and 12 - 13 years

school attendance ability

Disqualifiers

psychomotor impairment

Trial 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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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%

Time frame
Day 1

Secondary outcomes

1

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

Children who do not respond to PPI testing and fulfilling the criteria on pHmetric and impedance examination. * Reflux hypersensitivity, defined as normal acid exposure time and a normal number of reflux events on 24-hour MII-pH monitoring, accompanied by a positive temporal association between reflux episodes and symptoms (SI ≥ 50% and/or SAP ≥ 95%) * Functional pyrosis, defined as normal acid exposure time and a normal number of reflux events on 24-hour MII-pH monitoring, with no temporal association between reflux episodes and symptoms (SI \< 50% and SAP \< 95%), and no major esophageal motility disorder

Time frame
Day 1
2

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

Quality of life (QoL) will be evaluated in all participants who (1) are diagnosed with GERD based on clinical, endoscopic, or pH-metric criteria or (2) undergo pHmetry/MII following a negative PPI test, which includes children subsequently classified as having functional pyrosis or reflux hypersensitivity according to the study diagnostic algorithm. QoL will be evaluated using the Pediatric Quality of Life Inventory (PedsQL™) questionnaire, a validated instrument designed to assess health-related quality of life in children and adolescents. The PedsQL includes domains evaluating physical functioning, emotional functioning, social functioning, and school functioning. Participants (or their parents/guardians) will complete the age-appropriate PedsQL module. Responses are recorded on a 5-point Likert scale (0 = never a problem to 4 = almost always a problem) and subsequently transformed to a 0-100 scale, with higher scores indicating better health-related quality of life.

Time frame
Day 1

Other outcomes

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