The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants
NCT ID: NCT01807858
Last Updated: 2013-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2012-10-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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Bifidobacterium lactis
5 billion Bifidobacterium lactis
Bifidobacterium lactis plus İnülin
5 billion Bifidobacterium lactis plus 900 mg İnülin per day will be given
Maltodextrin
Maltodextrin
İnulin
900 mg inulin per day will be given
İnulin
900 mg İnulin per day will be given
Bifidobacterium lactis
5 billion active Bifidobacterium lactis
Bifidobacterium lactis plus İnülin
5 billion Bifidobacterium lactis plus 900 mg İnülin per day will be given
Maltodextrin
Maltodextrin
Maltodextrin
Maltodextrin
Bifidobacterium lactis
5 billion active Bifidobacterium lactis
Bifidobacterium lactis plus İnülin
5 billion Bifidobacterium lactis plus 900 mg İnülin per day will be given
İnulin
900 mg inulin per day will be given
Bifidobacterium lactis plus İnülin
5 billion active Bifidobacterium lactis plus 900 mg İnülin per day
Bifidobacterium lactis
5 billion active Bifidobacterium lactis
Maltodextrin
Maltodextrin
İnulin
900 mg inulin per day will be given
Interventions
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Bifidobacterium lactis
5 billion active Bifidobacterium lactis
Bifidobacterium lactis plus İnülin
5 billion Bifidobacterium lactis plus 900 mg İnülin per day will be given
Maltodextrin
Maltodextrin
İnulin
900 mg inulin per day will be given
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* babies who could not be fed (any metabolic disorders, gastrointestinal system surgical disorders etc.),
* severe asphyxia,
* severe congenital anomaly
30 Days
ALL
Yes
Sponsors
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Dr. Sami Ulus Children's Hospital
OTHER
Responsible Party
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Dilek Dilli
Assoc Prof
Principal Investigators
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Dilek Dilli, MD
Role: PRINCIPAL_INVESTIGATOR
Assoc Prof
Locations
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Şevket Yılmaz Research Hospital
Bursa, , Turkey (Türkiye)
Diyarbakır Research Hospital
Diyarbakır, , Turkey (Türkiye)
Okmeydani Research Hospital
Istanbul, , Turkey (Türkiye)
Umraniye Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Dilek Dilli, Assoc Prof
Role: CONTACT
Facility Contacts
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Arzu Akdağ, MD
Role: primary
Banu Mutlu, MD
Role: primary
Özden Turan, MD
Role: primary
Özden Turan
Role: backup
Şenol Bozdağ, MD
Role: primary
References
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Fouhy F, Ross RP, Fitzgerald GF, Stanton C, Cotter PD. 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.
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.
Related Links
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Are Probiotics Safe For Newborns? \| LIVESTRONG.COM
Other Identifiers
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68/16.Oct.2012
Identifier Type: -
Identifier Source: org_study_id
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