Synbiotics in Infants With Cyanotic Congenital Heart Disease
Efficacy of Synbiotics in Infants With Cyanotic Congenital Heart Disease
1 other identifier
interventional
100
1 country
1
Brief Summary
Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. The investigators hypothesized that synbiotics may reduce the rate of sepsis and necrotizing enterocolitis in infants with CHD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 12, 2013
CompletedFirst Posted
Study publicly available on registry
March 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMay 9, 2013
May 1, 2013
6 months
March 12, 2013
May 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sepsis
8 weeks
Secondary Outcomes (1)
Necrotizing enterocolitis
8 weeks
Study Arms (2)
Bifidobacterium lactis plus inulin
ACTIVE COMPARATORBifidobacterium lactis plus inulin
maltodextrin
PLACEBO COMPARATORmaltodextrin
Interventions
5 billion unit Bifidobacterium lactis plus 900 mg inulin per day will be given
same amount of maltodextrin per day will be given as placebo
Eligibility Criteria
You may qualify if:
- Cyanotic congenital heart disease
- infants \>35 weeks of gestational age
- Born at or transferred to Sami Ulus CH
You may not qualify if:
- Congenital anomalies of the intestinal tract
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sami Ulus CH
Ankara, Ankara, 06120, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 21468216RESULTDilli 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.
PMID: 24043284DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Banu Aydın, MD
MD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc Prof
Study Record Dates
First Submitted
March 12, 2013
First Posted
March 14, 2013
Study Start
October 1, 2012
Primary Completion
April 1, 2013
Study Completion
May 1, 2013
Last Updated
May 9, 2013
Record last verified: 2013-05