Cyanotic Congenital Heart Disease
Conditions
Keywords
cyanotic heart disease, congenital heart disease, intestinal microbiota, probiotics
Brief summary
Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. It is unknown how congenital heart disease affects the development of bacterial colonization of the intestines. It is also unknown whether probiotics will change the bacteria in the intestine of infants with heart disease to become more like those of healthy infants without heart disease. This pilot trial is designed to address these two questions.
Detailed description
Infants with cyanotic congenital heart disease will be randomly assigned to receive either a placebo or probiotic Bifidobacterium infantis. Comparisons will be made between the infants receiving the placebo and healthy infants without heart disease and between the infants receiving the placebo and those receiving the probiotic.
Interventions
DIETARY_SUPPLEMENTBifidobacterium infantis
1 billion organisms twice daily either through a feeding tube or by mouth for 4 months
OTHERPlacebo
A dilute preparation of pregestimil formula (similar in appearance to the probiotic product)
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 4 Months
Healthy volunteers
No
Inclusion criteria
* Cyanotic congenital heart disease * Term infant * Born at or transferred to UC Davis Children's hospital
Exclusion criteria
* Congenital anomalies of the intestinal tract
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal microbiota | Weekly for 4 weeks then monthly |
Countries
United States
Outcome results
None listed