NCT01018472

Probiotics in Infants With Cyanotic Congenital Heart Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 4 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Cyanotic Congenital Heart Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bifidobacterium infantis	1 billion organisms twice daily either through a feeding tube or by mouth for 4 months
OTHER	Placebo	A dilute preparation of pregestimil formula (similar in appearance to the probiotic product)

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-02-01
• Completion: 2011-12-01
• First posted: 2009-11-23
• Last updated: 2014-12-02

Locations

1 site across 1 country: United States