Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT03608735
Status:
COMPLETED
Last Update Posted:
2020-01-06
First Post:
2018-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Functional Gastrointestinal Disorders (FGIDs), Related Signs and Symptoms in Infants/Toddlers in Thailand
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7908}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-03', 'studyFirstSubmitDate': '2018-07-17', 'studyFirstSubmitQcDate': '2018-07-30', 'lastUpdatePostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To determine use of medication for the management of FGID via Adapted Parent Report Form for Infants and Toddlers Questionnaire on Paediatric Gastrointestinal Symptoms, Rome IV (R4PDQ-toddler)', 'timeFrame': '1 day', 'description': 'Use of medications for FGIDs and related signs and symptoms Use of treatments (other than medications or nutritional supplements) for FGIDs and related signs and symptoms Use of nutritional supplements for FGIDs and related signs and symptoms Use of other remedies for FGIDs and related signs and symptoms Visit to doctor, healthcare professional, clinic, and/or hospital for FGIDs and related signs and symptoms'}, {'measure': 'To determine use of treatment for the management of FGID via Adapted Parent Report Form for Infants and Toddlers Questionnaire on Paediatric Gastrointestinal Symptoms, Rome IV (R4PDQ-toddler)', 'timeFrame': '1 day', 'description': 'Use of treatment (other than medication) for FGIDs and related signs and symptoms Use of treatments (other than medications or nutritional supplements) for FGIDs and related signs and symptoms Use of nutritional supplements for FGIDs and related signs and symptoms Use of other remedies for FGIDs and related signs and symptoms Visit to doctor, healthcare professional, clinic, and/or hospital for FGIDs and related signs and symptoms'}, {'measure': 'To determine use of nutritional supplements for the management of FGID via Adapted Parent Report Form for Infants and Toddlers Questionnaire on Paediatric Gastrointestinal Symptoms, Rome IV (R4PDQ-toddler)', 'timeFrame': '1 day', 'description': 'Use of supplements for FGIDs and related signs and symptoms Use of treatments (other than medications or nutritional supplements) for FGIDs and related signs and symptoms Use of nutritional supplements for FGIDs and related signs and symptoms Use of other remedies for FGIDs and related signs and symptoms Visit to doctor, healthcare professional, clinic, and/or hospital for FGIDs and related signs and symptoms'}, {'measure': 'To determine use of other remedies for the management of FGID via Adapted Parent Report Form for Infants and Toddlers Questionnaire on Paediatric Gastrointestinal Symptoms, Rome IV (R4PDQ-toddler)', 'timeFrame': '1 day', 'description': 'Use of other remedies (other than medication, supplements) for FGIDs and related signs and symptoms Use of treatments (other than medications or nutritional supplements) for FGIDs and related signs and symptoms Use of nutritional supplements for FGIDs and related signs and symptoms Use of other remedies for FGIDs and related signs and symptoms Visit to doctor, healthcare professional, clinic, and/or hospital for FGIDs and related signs and symptoms'}, {'measure': 'Visit to doctor, healthcare professional, clinic, and/or hospital for FGIDs and related signs and symptoms via Adapted Parent Report Form for Infants and Toddlers Questionnaire on Paediatric Gastrointestinal Symptoms, Rome IV (R4PDQ-toddler)', 'timeFrame': '1 day', 'description': 'Visit to doctor, healthcare professional, clinic, and/or hospital for FGIDs and related signs and symptoms'}], 'primaryOutcomes': [{'measure': 'To determine the ROME IV Criteria score', 'timeFrame': '1 day', 'description': "FGIDs according to the ROME IV criteria (infant regurgitation, infantile colic, and functional constipation), related signs and symptoms in infants and toddlers based on parent's response in the survey questionnaires. Scale measures 1-7"}], 'secondaryOutcomes': [{'measure': 'To measure Quality of Life using modified Pediatric Quality of Life Inventory™', 'timeFrame': '1 day', 'description': 'Pediatric Quality of Life Inventory of the parents/caretakers and the family (using modified PedsQL™ Family Impact Module, Scale 0 -144)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Functional Gastrointestinal Disorders']}, 'descriptionModule': {'briefSummary': 'Prevalence and impact of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and Symptoms in Infants and Toddlers in Thailand', 'detailedDescription': 'Primary:\n\nTo assess the prevalence of specific FGIDs (infant regurgitation, infantile colic and functional constipation) and related signs and symptoms in infants and toddlers in Thailand, according to information provided by the parents.\n\nSecondary:\n\nTo assess the impact of FGIDs (Infant regurgitation, Infantile colic and functional constipation) and related signs and symptoms of infants and toddlers on the quality of life (QoL) of parents/caretakers and family, according to information provided by the parents.\n\nExploratory:\n\nTo assess treatments and practices employed in real-life to manage FGIDs according to the Rome IV criteria (infant regurgitation, infantile colic, and functional constipation) and related signs and symptoms in infants and toddlers, according to information provided by the parents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '19 Months', 'minimumAge': '2 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'otherwise healthy infants and toddlers aged 2 to 19 months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Parent of otherwise healthy infants and/or toddlers from one of the age groups: 3±1 months, 6±1 months, 9±1 months, 12±1 months, or 18±1 months\n2. Parent answering the online survey questionnaire attends to the child more than 50% of the time\n3. Informed consent from one or both parents (according to local laws) and/or legal guardian.\n4. Parent should have reliable access to the internet and a reliable device such as a computer, tablet or smartphone to complete the online survey questionnaire\n\nExclusion Criteria:\n\n1. Parent who is not adequately comfortable in the language in which the online survey questionnaire will be completed\n2. Inability of the parent to answer the survey questionnaire online.\n3. Infants and Toddlers who underwent surgery under general anesthesia'}, 'identificationModule': {'nctId': 'NCT03608735', 'acronym': 'GI_Planet', 'briefTitle': 'Prevalence of Functional Gastrointestinal Disorders (FGIDs), Related Signs and Symptoms in Infants/Toddlers in Thailand', 'organization': {'class': 'INDUSTRY', 'fullName': 'Danone Asia Pacific Holdings Pte, Ltd.'}, 'officialTitle': 'Prevalence of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and Symptoms in Infants and Toddlers in Thailand', 'orgStudyIdInfo': {'id': 'EBB17GC17070_1 / OBVIO-DAN-004'}}, 'contactsLocationsModule': {'locations': [{'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'Khon Kaen University', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}], 'overallOfficials': [{'name': 'Busara Charoenwat, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Khon Kaen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danone Asia Pacific Holdings Pte, Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ObvioHealth', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}