Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-28 @ 9:53 PM
Study NCT ID:
NCT06665503
Status:
COMPLETED
Last Update Posted:
2024-11-12
First Post:
2024-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Zinc and Probiotics in Preventing Pediatric Antibiotic-Associated Diarrhea in Southern Iran
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomly assigned to three groups of equal size, exclusively receiving the standard antibiotic regimen or the zinc and probiotics groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-08', 'studyFirstSubmitDate': '2024-10-29', 'studyFirstSubmitQcDate': '2024-10-29', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Antibiotic-Associated Diarrhea', 'timeFrame': '6 month', 'description': 'Passing loose, watery stools three or more times a day after taking antibiotic by questionnaire.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antibiotic-associated diarrhea', 'children zinc, probiotics', 'zinc', 'probiotics'], 'conditions': ['Antibiotic-associated Diarrhea', 'Diarrhea']}, 'descriptionModule': {'briefSummary': 'The Impact of Zinc and Probiotics in Preventing Pediatric Antibiotic-Associated Diarrhea in Southern Iran', 'detailedDescription': 'The participants will be children aged 3 months to 3 years.The zinc group received oral zinc supplementation; 2.5 ml every 12 hours for children aged \\<1 year and 5 ml every 12 hours for older children; the probiotics group received oral probiotics; 1 probiotic sachet; and the control group received nothing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '3 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. children aged 3 months to 3 years\n2. prescribed antibiotics for various medical conditions\n\nExclusion Criteria:\n\n1. Diarrhea, Dysentery\n2. Underlying chronic disease'}, 'identificationModule': {'nctId': 'NCT06665503', 'acronym': 'AAD', 'briefTitle': 'The Impact of Zinc and Probiotics in Preventing Pediatric Antibiotic-Associated Diarrhea in Southern Iran', 'organization': {'class': 'OTHER', 'fullName': 'Hormozgan University of Medical Sciences'}, 'officialTitle': 'The Impact of Zinc and Probiotics in Preventing Pediatric Antibiotic-Associated Diarrhea in Southern Iran', 'orgStudyIdInfo': {'id': 'IR.HUMS.REC.1399.579'}, 'secondaryIdInfos': [{'id': 'Hormozgan University', 'type': 'OTHER', 'domain': 'Hormozgan University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '65 children in cotrol group', 'description': 'Only standard medication.'}, {'type': 'EXPERIMENTAL', 'label': '65 children in Zinc group', 'description': 'The zinc group received oral zinc supplementation; 2.5 ml every 12 hours for children aged \\<1 year and 5 ml every 12 hours for older children.', 'interventionNames': ['Dietary Supplement: Zinc Supplement, probiotic']}, {'type': 'EXPERIMENTAL', 'label': '65 children in Probiotic group', 'description': 'The probiotics group received oral probiotics; 1 probiotic sachet (KidiLact: Lacticaseibacillus rhamnosus, Lactobacillus reuteri, Lactobacillus acidophilus, Bifidobacterium infantis, Lactobacillus acidophilus, Bifidobacterium bifidum and Streptococcus thermophilus)', 'interventionNames': ['Dietary Supplement: Zinc Supplement, probiotic']}], 'interventions': [{'name': 'Zinc Supplement, probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'received oral zinc supplementation; 2.5 ml every 12 hours for children aged \\<1 year and 5 ml every 12 hours for older children; the probiotics group received oral probiotics; 1 probiotic sachet', 'armGroupLabels': ['65 children in Probiotic group', '65 children in Zinc group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7915893664', 'city': 'Bandar Abbas', 'state': 'Hormozgan', 'country': 'Iran', 'facility': 'Hormozgan University of Medical Sciences', 'geoPoint': {'lat': 27.1865, 'lon': 56.2808}}], 'overallOfficials': [{'name': 'MohammadBagher Rahmati, Pediatrician', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hormozgan University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'October 2024-January 2026', 'ipdSharing': 'YES', 'description': 'all collected IPD', 'accessCriteria': 'For independent reviewers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hormozgan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hormozgan University of Medical Sciences', 'investigatorFullName': 'Mohammad Bagher Rahmati', 'investigatorAffiliation': 'Hormozgan University of Medical Sciences'}}}}