Gastro Esophageal RefluxCzech GERDKidsNCT07482969
Prevalence of Symptomatic Gastroesophageal Reflux Disease in Czech Children (Czech GERDKids)
An observational study of Gastro Esophageal Reflux, run by University Hospital, Motol at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Gastro Esophageal Reflux
- How many people
- 1,000 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Dec 2025to 30 Dec 2028
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- age group of 8 - 9 years and 12 - 13 years
- school attendance ability
Who cannot join
- psychomotor impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Motol University Hospital
Prague
Tereza Lerchova, +420775201573, terezadrskova@gmail.com
About this study
Official title: Prevalence of Symptomatic Gastroesophageal Reflux Disease in Children in the Czech Republic
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.
Read the detailed description
This cross-sectional, population-based study is designed to estimate the prevalence of symptomatic gastroesophageal reflux disease (GERD) in children aged 8-9 years and 12-13 years in the Czech Republic. The study uses a multi-stage, guideline-based diagnostic algorithm to differentiate confirmed GERD from functional pyrosis and reflux hypersensitivity. Participants are recruited through primary schools and grammar schools selected to reflect national demographic characteristics. Parents and children receive study information and a link to a secure web-based survey. The initial questionnaire collects data on oesophageal symptoms (pyrosis and regurgitation), prior proton pump inhibitor (PPI) use, and selected demographic and environmental variables. Children reporting symptoms suggestive of GERD proceed through a structured diagnostic pathway. The first step is a standardized PPI trial, consisting of 14 days of symptom recording before and 14 days during PPI therapy at an age-appropriate dose. A clinically meaningful reduction in symptom intensity is considered diagnostic for GERD. Children without a positive response undergo upper endoscopy to evaluate for esophagitis (Los Angeles grade C/D), strictures, or Barrett's esophagus. If endoscopy is normal or inconclusive, 24-hour pH-impedance monitoring is performed to assess reflux burden and symptom association. Findings are classified into GERD, reflux hypersensitivity, or functional pyrosis according to established consensus criteria. All participants undergoing PPI testing, endoscopy, or pH-impedance monitoring complete a validated pediatric quality-of-life assessment to characterize the functional impact of symptoms across diagnostic categories. Epidemiologic and demographic variables collected in the initial survey will be used to evaluate potential risk factors for symptomatic GERD. The study follows standard clinical procedures routinely performed at the investigators' institution. All data are de-identified and stored in a secure REDCap database. Results will inform prevalence estimates of pediatric symptomatic GERD in Central Europe and support future clinical guidance and public health planning.
Administrative Information Sponsor: University Hospital in Motol Principal Investigator: Tereza Lerchova, M.D., Ph.D. Co-Investigators: Associate Professor Ondrej Hradsky, M.D., Ph.D.; Jana Duskova, MD; Professor Jiri Bronsky, M.D., Ph.D.
Study Sites: Nationwide (primary schools across the Czech Republic) Trial Registration: [To be assigned - ClinicalTrials.gov]
The project has been supported by the Czech Health Research Council (CHRC): project number NW25J-09-00146.
- Conditions
- Gastro Esophageal Reflux
- Keywords
- Reflux disease, Children, Prevalence, Population
- Medical subject headings
- Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
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):
- 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
- Endoscopical definition: reflux esophagitis according to Los Angeles classification grade 3 and 4, stricture, Barrett's oesophagus
- Functional examination with pHmetry with impedance (pHmetry/MII): reflux index above 6%
Measured: Day 1
Secondary outcomes (2)
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
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start20 Dec 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tereza Lerchova, University Hospital, Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482969
- Sponsor's protocol ID
- GERD-CZ-2025
- Other IDs
- NW25J-09-00146
- Acronym
- Czech GERDKids
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Symptomatic Gastroesophageal Reflux Disease in Children in the Czech Republic
- ClinicalTrials.gov ID
- NCT07482969
- Acronym / sponsor ID
- Czech GERDKids / GERD-CZ-2025
- Conditions
- Gastro Esophageal Reflux
- Keywords
- Reflux disease, Children, Prevalence, Population
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This cross-sectional, population-based study is designed to estimate the prevalence of symptomatic gastroesophageal reflux disease (GERD) in children aged 8-9 years and 12-13 years in the Czech Republic. The study uses a multi-stage, guideline-based diagnostic algorithm to differentiate confirmed GERD from functional pyrosis and reflux hypersensitivity. Participants are recruited through primary schools and grammar schools selected to reflect national demographic characteristics. Parents and children receive study information and a link to a secure web-based survey. The initial questionnaire collects data on oesophageal symptoms (pyrosis and regurgitation), prior proton pump inhibitor (PPI) use, and selected demographic and environmental variables. Children reporting symptoms suggestive of GERD proceed through a structured diagnostic pathway. The first step is a standardized PPI trial, consisting of 14 days of symptom recording before and 14 days during PPI therapy at an age-appropriate dose. A clinically meaningful reduction in symptom intensity is considered diagnostic for GERD. Children without a positive response undergo upper endoscopy to evaluate for esophagitis (Los Angeles grade C/D), strictures, or Barrett's esophagus. If endoscopy is normal or inconclusive, 24-hour pH-impedance monitoring is performed to assess reflux burden and symptom association. Findings are classified into GERD, reflux hypersensitivity, or functional pyrosis according to established consensus criteria. All participants undergoing PPI testing, endoscopy, or pH-impedance monitoring complete a validated pediatric quality-of-life assessment to characterize the functional impact of symptoms across diagnostic categories. Epidemiologic and demographic variables collected in the initial survey will be used to evaluate potential risk factors for symptomatic GERD. The study follows standard clinical procedures routinely performed at the investigators' institution. All data are de-identified and stored in a secure REDCap database. Results will inform prevalence estimates of pediatric symptomatic GERD in Central Europe and support future clinical guidance and public health planning.
Administrative Information Sponsor: University Hospital in Motol Principal Investigator: Tereza Lerchova, M.D., Ph.D. Co-Investigators: Associate Professor Ondrej Hradsky, M.D., Ph.D.; Jana Duskova, MD; Professor Jiri Bronsky, M.D., Ph.D.
Study Sites: Nationwide (primary schools across the Czech Republic) Trial Registration: [To be assigned - ClinicalTrials.gov]
The project has been supported by the Czech Health Research Council (CHRC): project number NW25J-09-00146.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- age group of 8 - 9 years and 12 - 13 years
- school attendance ability
Key exclusion criteria (1 listed)
- psychomotor impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with Gastroesophageal Reflux Disease by Lyon consensus
Time frame: 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%
2 secondary outcomes
Number of participants with Functional pyrosis and Reflux hypersensitivity by Lyon consensus
Time frame: Day 1
Quality of life of patients with confirmed GERD, functional pyrosis or reflux hypersensitivity
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastro Esophageal Reflux, run by University Hospital, Motol at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tereza Lerchova (+420775201573, terezadrskova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Gastroesophageal Reflux Disease by Lyon consensus (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.