Probiotics in Infants With Cyanotic Congenital Heart Disease
- Conditions
- Cyanotic Congenital Heart Disease
- Interventions
- Dietary Supplement: Bifidobacterium infantisOther: Placebo
- Registration Number
- NCT01018472
- Lead Sponsor
- University of California, Davis
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Cyanotic congenital heart disease
- Term infant
- Born at or transferred to UC Davis Children's hospital
- Congenital anomalies of the intestinal tract
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bifidobacterium infantis Bifidobacterium infantis - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Fecal microbiota Weekly for 4 weeks then monthly
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UC Davis Children's Hospital
🇺🇸Sacramento, California, United States