Synbiotics in Infants With Cyanotic Congenital Heart Disease
NCT ID: NCT01810978
Last Updated: 2013-05-09
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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COMPLETED
NA
100 participants
INTERVENTIONAL
2012-10-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Bifidobacterium lactis plus inulin
Bifidobacterium lactis plus inulin
Maltodextrin
same amount of maltodextrin per day will be given as placebo
maltodextrin
maltodextrin
Bifidobacterium lactis plus inulin
5 billion unit Bifidobacterium lactis plus 900 mg inulin per day will be given
Interventions
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Bifidobacterium lactis plus inulin
5 billion unit Bifidobacterium lactis plus 900 mg inulin per day will be given
Maltodextrin
same amount of maltodextrin per day will be given as placebo
Eligibility Criteria
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Inclusion Criteria
* infants \>35 weeks of gestational age
* Born at or transferred to Sami Ulus CH
Exclusion Criteria
1 Day
3 Months
ALL
No
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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Banu Aydın, MD
Role: PRINCIPAL_INVESTIGATOR
MD
Locations
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Sami Ulus CH
Ankara, Ankara, Turkey (Türkiye)
Countries
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References
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Ellis CL, Rutledge JC, Underwood MA. Intestinal microbiota and blue baby syndrome: probiotic therapy for term neonates with cyanotic congenital heart disease. Gut Microbes. 2010 Nov-Dec;1(6):359-66. doi: 10.4161/gmic.1.6.14077.
Dilli D, Aydin B, Zenciroglu A, Ozyazici E, Beken S, Okumus N. Treatment outcomes of infants with cyanotic congenital heart disease treated with synbiotics. Pediatrics. 2013 Oct;132(4):e932-8. doi: 10.1542/peds.2013-1262. Epub 2013 Sep 16.
Related Links
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http://www.ncbi.nlm.nih.gov/pubmed/21468216
Other Identifiers
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128/01.10.2012
Identifier Type: -
Identifier Source: org_study_id
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