Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-27 @ 4:10 PM
Study NCT ID:
NCT06962761
Status:
COMPLETED
Last Update Posted:
2025-05-08
First Post:
2025-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Effect of Use of Vit d and Probiotic as a Supplementaition in the Treatment of Bronchial Asthma in Patient Aged 6 to 50 Year and Its Effect in Decrasing Excerbation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2025-04-30', 'studyFirstSubmitQcDate': '2025-04-30', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'asthma control test', 'timeFrame': '3,6 and 12 months', 'description': 'The ACT has five questions and assesses the frequency of shortness of breath and general asthma symptoms, the use of rescue medications, the effect of asthma on daily functioning, and an overall self-assessment of asthma control in the last four weeks. Scores range from 5 (poor control of asthma) to 25 (complete control of asthma), and high scores reflect greater degrees of asthma control. Asthma is classified as controlled if the score is greater than 19'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchial Asthma']}, 'descriptionModule': {'briefSummary': 'the study of the effect of vit d and probiotic as suprplementaion in the treatment of patient with bonchial asthma and its effect in decreasing number of excerbation', 'detailedDescription': 'the study of the effect of vit d and probiotic as suprplementaion in the treatment of patient with bonchial asthma and its effect in decreasing number of excerbation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patient wih bronchial asthma', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: patient wih bronchial asthma aged 6 to50years -\n\nExclusion Criteria: other comorbities\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06962761', 'acronym': 'asthma', 'briefTitle': 'the Effect of Use of Vit d and Probiotic as a Supplementaition in the Treatment of Bronchial Asthma in Patient Aged 6 to 50 Year and Its Effect in Decrasing Excerbation.', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Impact of Vit D and Probiotic As a Supplementary Therapy in The Treatment of PatientWith Bronchial Asthma', 'orgStudyIdInfo': {'id': 'MSC\\AZ.AST\\C11T019\\29\\227'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'adult and children with bronchial asthma', 'description': '4 groups 2adult groups 1take the vitd and probiotic andregulartreatment of asthma and another take regulartreatment of asthma only 2 children groups 1take the vitd and probiotic andregulartreatment of asthma and another take regulartreatment of asthma only', 'interventionNames': ['Drug: Vit D']}], 'interventions': [{'name': 'Vit D', 'type': 'DRUG', 'otherNames': ['probiotics'], 'description': 'in this study we use a combination of vit d and probiotics', 'armGroupLabels': ['adult and children with bronchial asthma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71717', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'ALAzhar university hospital assiut', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor of chest department Al-Azhar university asyut', 'investigatorFullName': 'abdelrahman ahmed mohamed ibrahim', 'investigatorAffiliation': 'Al-Azhar University'}}}}