Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-24 @ 4:56 PM
Study NCT ID:
NCT04320550
Status:
UNKNOWN
Last Update Posted:
2020-03-26
First Post:
2020-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Frequency of Functional Gastrointestinal Disorders in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001772', 'term': 'Blood Cell Count'}], 'ancestors': [{'id': 'D002452', 'term': 'Cell Count'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 246}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2020-03-23', 'studyFirstSubmitQcDate': '2020-03-23', 'lastUpdatePostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'structural or biochemical abnormalities', 'timeFrame': '1 week', 'description': 'percentage of causes of patholological recurrent abdominal pain'}], 'primaryOutcomes': [{'measure': 'no structural or biochemical abnormality', 'timeFrame': '1 week', 'description': 'percentage of functional gastrointestinal disorders'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['abdominal pain', 'recurrent'], 'conditions': ['Functional Abdominal Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '30216016', 'type': 'RESULT', 'citation': 'Reust CE, Williams A. Recurrent Abdominal Pain in Children. Am Fam Physician. 2018 Jun 15;97(12):785-793.'}, {'pmid': '28594620', 'type': 'RESULT', 'citation': 'Chopra J, Patel N, Basude D, Gil-Zaragozano E, Paul SP. Abdominal pain-related functional gastrointestinal disorders in children. Br J Nurs. 2017 Jun 8;26(11):624-631. doi: 10.12968/bjon.2017.26.11.624.'}]}, 'descriptionModule': {'briefSummary': 'cross sectional study to detect frequency of functional gastrointestinal disorders among schhol aged children complaining of recurrent abdominal pain', 'detailedDescription': 'school aged children from age of 5 to age of 15 who are complaining of recurrent abdominal pain will be included in the study , detailed history , examination and investigations will be done'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children with recurrent abdominal pain will be subjected to medical history , detailed examination and some investigations', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of recurrent abdominal pain\n* the child can express and locate site of the pain\n\nExclusion Criteria:\n\n* children less than 5 and adolescents more than 14\n* mentally retarded children'}, 'identificationModule': {'nctId': 'NCT04320550', 'briefTitle': 'Frequency of Functional Gastrointestinal Disorders in Children', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Frequency of Functional Gastrointestinal Disorders Among School Aged Children', 'orgStudyIdInfo': {'id': 'FGIDs'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'abdominal pain', 'description': 'one group of children complaining of recurrent abdominal pain', 'interventionNames': ['Diagnostic Test: abdominal ultra sound']}], 'interventions': [{'name': 'abdominal ultra sound', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['complete blood count', 'Erythrocyte sidementation rate', 'C reactive protein'], 'description': 'non invasive tests to exclude pathological causes', 'armGroupLabels': ['abdominal pain']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Hend Ali Zohrey', 'investigatorAffiliation': 'Assiut University'}}}}