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Probiotics in Infants With Cyanotic Congenital Heart Disease

NCT01018472 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-12-02

No results posted yet for this study

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.

Conditions

  • Cyanotic Congenital Heart Disease

Interventions

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)

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Mark A. Underwood, MD · UC Davis School of Medicine

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-02-28
Completion
2011-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01018472 on ClinicalTrials.gov