Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-03-01 @ 10:01 AM
Study NCT ID:
NCT01807858
Status:
UNKNOWN
Last Update Posted:
2013-03-08
First Post:
2012-12-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants
Sponsor:
Organization:
Raw JSON
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Composition of the early intestinal microbiota: knowledge, knowledge gaps and the use of high-throughput sequencing to address these gaps. Gut Microbes. 2012 May-Jun;3(3):203-20. doi: 10.4161/gmic.20169. Epub 2012 May 1.'}, {'pmid': '25596096', 'type': 'DERIVED', 'citation': 'Dilli D, Aydin B, Fettah ND, Ozyazici E, Beken S, Zenciroglu A, Okumus N, Ozyurt BM, Ipek MS, Akdag A, Turan O, Bozdag S. The propre-save study: effects of probiotics and prebiotics alone or combined on necrotizing enterocolitis in very low birth weight infants. J Pediatr. 2015 Mar;166(3):545-51.e1. doi: 10.1016/j.jpeds.2014.12.004. Epub 2015 Jan 13.'}], 'seeAlsoLinks': [{'url': 'http://www.livestrong.com/article/468506-are-probiotics-safe-for-newborns/', 'label': 'Are Probiotics Safe For Newborns? \\| LIVESTRONG.COM'}]}, 'descriptionModule': {'briefSummary': 'Study, the inclusion of very low birth weight premature infants followed in Dr.Sami Ulus Maternity and Children Training and Research Hospital, Department of Neonatology; be randomized to very low birth weight premature infants began eating until you are discharged from the hospital once a day to feed a group+ 900 mg of 5 billion active Bifidobacterium lactis, the addition of chicory inulin, in the other group given placebo; Patients taking weekly blood cultures, the presence of residues in both groups during feeding, to evaluate the incidence of NEC and sepsis are planned. Randomization and the number of patients planned to separate into groups.', 'detailedDescription': 'Patients separated into four groups using the sealed envelope method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* VLBW infants admitted to NICU at the first 7 days of life\n\nExclusion Criteria:\n\n* expected life lower than 7 days,\n* babies who could not be fed (any metabolic disorders, gastrointestinal system surgical disorders etc.),\n* severe asphyxia,\n* severe congenital anomaly'}, 'identificationModule': {'nctId': 'NCT01807858', 'briefTitle': 'The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': "Dr. Sami Ulus Children's Hospital"}, 'officialTitle': 'The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants', 'orgStudyIdInfo': {'id': '68/16.Oct.2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bifidobacterium lactis', 'description': '5 billion Bifidobacterium lactis', 'interventionNames': ['Dietary Supplement: Bifidobacterium lactis plus İnülin', 'Other: Maltodextrin', 'Dietary Supplement: İnulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'İnulin', 'description': '900 mg İnulin per day will be given', 'interventionNames': ['Dietary Supplement: Bifidobacterium lactis', 'Dietary Supplement: Bifidobacterium lactis plus İnülin', 'Other: Maltodextrin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Maltodextrin', 'description': 'Maltodextrin', 'interventionNames': ['Dietary Supplement: Bifidobacterium lactis', 'Dietary Supplement: Bifidobacterium lactis plus İnülin', 'Dietary Supplement: İnulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bifidobacterium lactis plus İnülin', 'description': '5 billion active Bifidobacterium lactis plus 900 mg İnülin per day', 'interventionNames': ['Dietary Supplement: Bifidobacterium lactis', 'Other: Maltodextrin', 'Dietary Supplement: İnulin']}], 'interventions': [{'name': 'Bifidobacterium lactis', 'type': 'DIETARY_SUPPLEMENT', 'description': '5 billion active Bifidobacterium lactis', 'armGroupLabels': ['Bifidobacterium lactis plus İnülin', 'Maltodextrin', 'İnulin']}, {'name': 'Bifidobacterium lactis plus İnülin', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['5 billion Bifidobacterium lactis plus 900 mg İnülin'], 'description': '5 billion Bifidobacterium lactis plus 900 mg İnülin per day will be given', 'armGroupLabels': ['Bifidobacterium lactis', 'Maltodextrin', 'İnulin']}, {'name': 'Maltodextrin', 'type': 'OTHER', 'description': 'Maltodextrin', 'armGroupLabels': ['Bifidobacterium lactis', 'Bifidobacterium lactis plus İnülin', 'İnulin']}, {'name': 'İnulin', 'type': 'DIETARY_SUPPLEMENT', 'description': '900 mg inulin per day will be given', 'armGroupLabels': ['Bifidobacterium lactis', 'Bifidobacterium lactis plus İnülin', 'Maltodextrin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bursa', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Arzu Akdağ, MD', 'role': 'CONTACT'}, {'name': 'Arzu Akdağ, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Şevket Yılmaz Research Hospital', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}, {'city': 'Diyarbakır', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Banu Mutlu, MD', 'role': 'CONTACT'}, {'name': 'M. Şah Oğuz, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Diyarbakır Research Hospital', 'geoPoint': {'lat': 37.91363, 'lon': 40.21721}}, {'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Özden Turan, MD', 'role': 'CONTACT'}, {'name': 'Özden Turan', 'role': 'CONTACT'}, {'name': 'Özden Turan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Okmeydani Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Şenol Bozdağ, MD', 'role': 'CONTACT'}, {'name': 'Şenol Bozdağ', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Umraniye Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Dilek Dilli, Assoc Prof', 'role': 'CONTACT', 'phone': '00903123055000'}], 'overallOfficials': [{'name': 'Dilek Dilli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assoc Prof'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Sami Ulus Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof', 'investigatorFullName': 'Dilek Dilli', 'investigatorAffiliation': "Dr. Sami Ulus Children's Hospital"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-08-01', 'type': 'RELEASE'}, {'date': '2014-08-19', 'type': 'RESET'}, {'date': '2014-08-20', 'type': 'RELEASE'}, {'date': '2014-08-31', 'type': 'RESET'}, {'date': '2015-02-19', 'type': 'RELEASE'}, {'date': '2015-03-04', 'type': 'RESET'}], 'unpostedResponsibleParty': "Dilek Dilli, Assoc Prof, Dr. Sami Ulus Children's Hospital"}}}}