Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT07168304
Status:
COMPLETED
Last Update Posted:
2025-09-11
First Post:
2025-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Zinc Plus Saccharomyces Boulardii Versus Zinc Alone in the Treatment of Acute Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 276}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2025-09-04', 'studyFirstSubmitQcDate': '2025-09-04', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of diarrhea', 'timeFrame': '7 days', 'description': 'The duration from initiation of treatment until passage of normal stools (Bristol Stool Form Scale types 3-4).'}, {'measure': 'Resolution of vomiting', 'timeFrame': '14 hours', 'description': 'The time from the start of treatment to the last episode of vomiting.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Watery Diarrhea']}, 'descriptionModule': {'briefSummary': 'In literature combined therapy of zinc with S. boulardii in the treatment of acute diarrhea has not been addressed satisfactorily in the recent past. Therefore, this study was planned aiming to compare the mean time taken to resolve diarrhea and the mean time taken to resolve vomiting in children under 5 years of age having acute diarrhea with zinc plus S. boulardii versus zinc alone.', 'detailedDescription': 'Zinc has been used as a recommended choice treating acute watery ailments among children. If any significant beneficial effect in the combined efficacy of zinc with S. boulardii is found, it may add on to pre-existing knowledge and may lead clinicians to delineate the treatment guidelines to provide more effective treatment to the patients in clinical practices to reduce undesirable morbidity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children of either gender\n* Aged between 1 month up to 5 years\n* Presented with acute diarrhea\n\nExclusion Criteria:\n\n* Children with concurrent acute illnesses (meningitis, sepsis, or pneumonia)\n* Severe chronic conditions (cystic fibrosis, endocrinopathies, food allergies, or chronic gastrointestinal diseases)\n* Severe undernutrition (weight-for-age \\<60% of the 50th percentile of CDC 2000 standards)\n* Children who used probiotics, antibiotics, or anti-diarrheal drugs within the past 7 days\n* The presence of visible blood in stools'}, 'identificationModule': {'nctId': 'NCT07168304', 'briefTitle': 'Zinc Plus Saccharomyces Boulardii Versus Zinc Alone in the Treatment of Acute Diarrhea', 'organization': {'class': 'OTHER', 'fullName': 'RESnTEC, Institute of Research'}, 'officialTitle': 'Clinical Outcome of Zinc Plus Saccharomyces Boulardii Versus Zinc Alone in the Treatment of Acute Diarrhea in Children Under 5 Years of Age', 'orgStudyIdInfo': {'id': 'Dr-Hammad-Multan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic group', 'description': 'Standard treatment plus S. boulardii', 'interventionNames': ['Drug: S. boulardii']}, {'type': 'NO_INTERVENTION', 'label': 'No probiotic group', 'description': 'Standard treatment only'}], 'interventions': [{'name': 'S. boulardii', 'type': 'DRUG', 'description': 'Participants received zinc plus S. boulardii supplementation according to the World Health Organization recommendations.', 'armGroupLabels': ['Probiotic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66000', 'city': 'Multan', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': "The Children's Hospital and The Institute of Child Health", 'geoPoint': {'lat': 30.19679, 'lon': 71.47824}}], 'overallOfficials': [{'name': 'Muhammad Hammad Riaz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital and institute of Child Health Multan, Punjab, Pakistan"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data can be shared on a reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhammad Aamir Latif', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Consultant', 'investigatorFullName': 'Muhammad Aamir Latif', 'investigatorAffiliation': 'RESnTEC, Institute of Research'}}}}