Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-27 @ 10:11 PM
Study NCT ID:
NCT01411761
Status:
UNKNOWN
Last Update Posted:
2011-08-08
First Post:
2011-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Saccharomyces Boulardii on Indirect Hyperbilirubinemia and Phototherapy Duration in Very Low Birth Weight Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-05', 'studyFirstSubmitDate': '2011-08-05', 'studyFirstSubmitQcDate': '2011-08-05', 'lastUpdatePostDateStruct': {'date': '2011-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of S. boulardii on severity of hyperbilirubinemia and phototherapy duration', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'long term effect of S.boulardii on neurodevelopmental outcome', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['indirect hyperbilirubinemia', 'very low birth weight infants'], 'conditions': ['Indirect Hyperbilirubinemia']}, 'descriptionModule': {'briefSummary': 'Indirect hyperbilirubinemia is frequently observed in premature infants.Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system. In this study we aimed to compare the effect of S. boulardii on severity of hyperbilirubinemia and duration of phototherapy on very low birth weight infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* very low birth weight infants\n\nExclusion Criteria:\n\n* chromosomal anomalies'}, 'identificationModule': {'nctId': 'NCT01411761', 'briefTitle': 'Effect of Saccharomyces Boulardii on Indirect Hyperbilirubinemia and Phototherapy Duration in Very Low Birth Weight Infants', 'organization': {'class': 'OTHER', 'fullName': "Zekai Tahir Burak Women's Health Research and Education Hospital"}, 'officialTitle': 'Phase 4 Study of Saccharomyces Boulardii on Indirect Hyperbilirubinemia', 'orgStudyIdInfo': {'id': 'demirel9800'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saccharomyces boulardii', 'description': 'study group', 'interventionNames': ['Dietary Supplement: Reflor']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'serum physiologic', 'interventionNames': ['Other: serum physiologic']}], 'interventions': [{'name': 'Reflor', 'type': 'DIETARY_SUPPLEMENT', 'description': '5 million unit/day, first 15 day of life', 'armGroupLabels': ['Saccharomyces boulardii']}, {'name': 'serum physiologic', 'type': 'OTHER', 'description': '1 cc added to one feeding in a day', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06230', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Gamze Demirel, MD', 'role': 'CONTACT', 'email': 'kgamze@hotmail.com', 'phone': '+905324540156'}, {'name': 'Omer Erdeve, Assoc Prof', 'role': 'CONTACT'}, {'name': 'Gamze Demirel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Gamze Demirel, MD', 'role': 'CONTACT', 'email': 'kgamze@hotmail.com', 'phone': '+905324540156'}], 'overallOfficials': [{'name': 'Gamze Demirel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Zekai Tahir Burak Women's Health Research and Education Hospital"}, {'name': 'Ugur Dilmen, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zekai Tahir Burak Maternit Teaching Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zekai Tahir Burak Women's Health Research and Education Hospital", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Zekai Tahir Burak Maternity and Teaching Hospital', 'oldOrganization': 'Zekai Tahir Burak Maternity and Teaching Hospital'}}}}