Probiotics in Infants With Cyanotic Congenital Heart Disease

University of California (UC) Davis

Status: Completed

Conditions: Cyanotic Congenital Heart Disease

Treatments: Other: Placebo; Dietary Supplement: Bifidobacterium infantis

Study type: Interventional

Funder types: Other

Identifiers

NCT01018472

200917427

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: Under 4 months old

Volunteers: No Healthy Volunteers

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

Trial design

12 participants in 2 patient groups, including a placebo group

Bifidobacterium infantis

Experimental group

Treatment:

Dietary Supplement: Bifidobacterium infantis

Placebo

Placebo Comparator group

Treatment:

Other: Placebo