Synbiotics in Infants With Cyanotic Congenital Heart Disease

NCT01810978 — Not applicable, Completed, 100 participants, Dr. Sami Ulus Children's Hospital

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Efficacy of Synbiotics in Infants With Cyanotic Congenital Heart Disease

Registry	NCT01810978
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	100 (Estimated)
Sponsor	Dr. Sami Ulus Children's Hospital (Other)
Conditions	Congenital Heart Disease
Interventions	Bifidobacterium lactis plus inulin, Maltodextrin (Dietary supplement)
Dates	start 2012-10-01, primary completion 2013-04-01, completion 2013-05-01, first posted 2013-03-14, last updated 2013-05-09
Locations	1 site in Turkey (Türkiye)

-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

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+Detailed description

Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. Probiotics may prevent pathogen colonization in infants with CHD. Therefore, the investigators hypothesized that synbiotics may reduce the rate of sepsis and necrotizing enterocolitis in infants with CHD

+Arms and interventions

Arm	Type	Interventions	Description
Bifidobacterium lactis plus inulin	Active comparator	Dietary Supplement: Maltodextrin	Bifidobacterium lactis plus inulin
maltodextrin	Placebo comparator	Dietary Supplement: Bifidobacterium lactis plus inulin	maltodextrin

Bifidobacterium lactis plus inulin (Dietary supplement): 5 billion unit Bifidobacterium lactis plus 900 mg inulin per day will be given
Maltodextrin (Dietary supplement): same amount of maltodextrin per day will be given as placebo

+Outcome measures

Primary outcomes

Sepsis [8 weeks]

Secondary outcomes

Necrotizing enterocolitis [8 weeks]

+Eligibility

Sex: All, ages: 1 Day to 3 Months

Inclusion Criteria:

* Cyanotic congenital heart disease
* infants >35 weeks of gestational age
* Born at or transferred to Sami Ulus CH

Exclusion Criteria:

* Congenital anomalies of the intestinal tract

+Locations (1)

Facility	City	Country	Status
Sami Ulus CH	Ankara, Ankara	Turkey (Türkiye)

+Publications

Results publication: 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 21468216
Results publication: 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. PMID 24043284

+Investigators

Banu Aydın, MD, Principal investigator, MD