Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-08 @ 9:27 PM
Study NCT ID:
NCT05605405
Status:
UNKNOWN
Last Update Posted:
2022-11-04
First Post:
2021-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Associated Factors of Functional Gastrointestinal Disorders Among Children
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': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 269}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-29', 'studyFirstSubmitDate': '2021-09-22', 'studyFirstSubmitQcDate': '2022-10-29', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of functional gastrointestinal disorders among children attending gastrointerology clinic of Assuit University Children Hospital', 'timeFrame': '50 weeks', 'description': 'A number will calculated'}, {'measure': 'The associated factors', 'timeFrame': '50 weeks', 'description': 'Demographic and social'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Functional Gastrointestinal Disorders']}, 'descriptionModule': {'briefSummary': 'The definition of Functional Gastrointestinal Disorders (FGIDs) has changed over time from the absence of organic disease to a stress-related or psychiatric disorder to a motility disorder, and with Rome III, to a disorder of GI functioning, then Rome iv in 2016 defined FGIDs as : disorders of gut-brain interaction. It is a group of disorders classified by GI symptoms related to any combination of the following: motility disturbance, visceral hypersensitivity,altered mucosal and immune function, altered gut microbiota, and altered central nervous system (CNS) processing. FGIDs are observed in infants and young children worldwide with variable frequency related studies done in variable places around the worled show the following results : the prevalence of FGIDs in Chinese infants and young children is 27.3%.and 40 % in south american infants and 30 % of african infants and 35.1 % of infants presented to tertiary care hospital in Istunbul.Turkey.', 'detailedDescription': 'The etiology of these disorders remains uncertain and thought to be due to subtle alteration of the normal development or maladaptive behavioral response to a variety of internal or external stimuli .As a group of disorders; FGIDs in young children are a major challenge to the already overstretched pediatric gastroenterology services across the world .Infants and young children with FGIDs visit medical professionals more frequently and experience poor quality of life . In addition, FGIDs in infancy are linked with detrimental repercussions such as maternal depression, poor infant and mother bonding,and poor physical growth .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children having functional GI symptoms according Rome IV criteria', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age group 1 to 18 years old\n\nExclusion Criteria:\n\n* Age group bwlow 1 year and above 18 years\n\nHaving other git problem as :\n\n* GIT bleeding\n* H pylori infection\n* Cow's milk protein allergy or IBD or any other symptoms suggestive to organic GI disease"}, 'identificationModule': {'nctId': 'NCT05605405', 'briefTitle': 'Prevalence and Associated Factors of Functional Gastrointestinal Disorders Among Children', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Prevalence and Associated Factors of Functional Gastrointestinal Disorders Among Children Attending Assuit University Children Hospital', 'orgStudyIdInfo': {'id': 'PAAFOFGDACAAUCH'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dalia Galal Mahran, MD', 'role': 'CONTACT', 'email': 'Daliaym2001@yahoo.com', 'phone': '01007120821'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prevalence and associated factors of functional gastrointestinal disorders among children attending Assuit University Children Hospital', 'investigatorFullName': 'Ahlam Osama', 'investigatorAffiliation': 'Assiut University'}}}}