Probiotics in Infants With Cyanotic Congenital Heart Disease

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.

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Key information

Conditions

Cyanotic Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

Up to 4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Children's Hospital

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bifidobacterium infantis

Dietary Supplement

1 billion organisms twice daily either through a feeding tube or by mouth for 4 months

Placebo

Other

A dilute preparation of pregestimil formula (similar in appearance to the probiotic product)

Primary outcomes

Fecal microbiota

Time frame: Weekly for 4 weeks then monthly

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Nov 23, 2009
Registry last updated: Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed