Probiotics in Infants With Cyanotic Congenital Heart Disease

Not Applicable

Completed

• Conditions: Cyanotic Congenital Heart Disease

• 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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-23
• Primary Completion: 2011-02
• Study Completion: 2011-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fecal microbiota	Weekly for 4 weeks then monthly

Trial Locations

Locations (1)

UC Davis Children's Hospital; 🇺🇸 Sacramento, California, United States