Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:13 AM
Study NCT ID:
NCT07482969
Status:
RECRUITING
Last Update Posted:
2026-03-19
First Post:
2025-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Symptomatic Gastroesophageal Reflux Disease in Czech Children (Czech GERDKids)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2025-11-23', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Gastroesophageal Reflux Disease by Lyon consensus', 'timeFrame': 'Day 1', 'description': "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.\n\nDetailed definition of GERD (according to the Lyon Consensus):\n\n1. 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\n2. Endoscopical definition: reflux esophagitis according to Los Angeles classification grade 3 and 4, stricture, Barrett's oesophagus\n3. Functional examination with pHmetry with impedance (pHmetry/MII): reflux index above 6%"}], 'secondaryOutcomes': [{'measure': 'Number of participants with Functional pyrosis and Reflux hypersensitivity by Lyon consensus', 'timeFrame': 'Day 1', 'description': 'Children who do not respond to PPI testing and fulfilling the criteria on pHmetric and impedance examination.\n\n* 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%)\n* 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'}, {'measure': 'Quality of life of patients with confirmed GERD, functional pyrosis or reflux hypersensitivity', 'timeFrame': 'Day 1', 'description': '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.\n\nQoL 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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Reflux disease', 'Children', 'Prevalence', 'Population'], 'conditions': ['Gastro Esophageal Reflux']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nAdministrative 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.\n\nStudy Sites: Nationwide (primary schools across the Czech Republic) Trial Registration: \\[To be assigned - ClinicalTrials.gov\\]\n\nThe project has been supported by the Czech Health Research Council (CHRC): project number NW25J-09-00146."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age group of 8 - 9 years and 12 - 13 years\n* school attendance ability\n\nExclusion Criteria:\n\n* psychomotor impairment'}, 'identificationModule': {'nctId': 'NCT07482969', 'acronym': 'Czech GERDKids', 'briefTitle': 'Prevalence of Symptomatic Gastroesophageal Reflux Disease in Czech Children (Czech GERDKids)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Motol'}, 'officialTitle': 'Prevalence of Symptomatic Gastroesophageal Reflux Disease in Children in the Czech Republic', 'orgStudyIdInfo': {'id': 'GERD-CZ-2025'}, 'secondaryIdInfos': [{'id': 'NW25J-09-00146', 'type': 'OTHER_GRANT', 'domain': 'Czech Health Research Council'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Tereza Lerchova', 'role': 'CONTACT', 'email': 'terezadrskova@gmail.com', 'phone': '+420775201573'}], 'facility': 'Motol University Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'Tereza Lerchova', 'role': 'CONTACT', 'email': 'terezadrskova@gmail.com', 'phone': '+420775201573'}, {'name': 'Jana Duskova', 'role': 'CONTACT', 'email': 'jancapavelcova@seznam.cz', 'phone': '+420733257719'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Motol', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D.', 'investigatorFullName': 'Tereza Lerchova', 'investigatorAffiliation': 'University Hospital, Motol'}}}}