Congenital Heart Disease
Conditions
Keywords
congenital heart disease, probiotic, prebiotic
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
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
Interventions
DIETARY_SUPPLEMENTBifidobacterium lactis plus inulin
5 billion unit Bifidobacterium lactis plus 900 mg inulin per day will be given
DIETARY_SUPPLEMENTMaltodextrin
same amount of maltodextrin per day will be given as placebo
Sponsors
Dr. Sami Ulus Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 3 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sepsis | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Necrotizing enterocolitis | 8 weeks |
Countries
Turkey (Türkiye)
Outcome results
None listed