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Probiotics in Infants With Cyanotic Congenital Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01018472
Recruitment Status : Completed
First Posted : November 23, 2009
Last Update Posted : December 2, 2014
Information provided by (Responsible Party):
University of California, Davis

November 19, 2009
November 23, 2009
December 2, 2014
November 2009
February 2011   (Final data collection date for primary outcome measure)
Fecal microbiota [ Time Frame: Weekly for 4 weeks then monthly ]
Same as current
Complete list of historical versions of study NCT01018472 on Archive Site
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Probiotics in Infants With Cyanotic Congenital Heart Disease
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.
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.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Cyanotic Congenital Heart Disease
  • 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)
  • Experimental: Bifidobacterium infantis
    Intervention: Dietary Supplement: Bifidobacterium infantis
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2011
February 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 4 Months   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
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University of California, Davis
University of California, Davis
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Principal Investigator: Mark A. Underwood, MD UC Davis School of Medicine
University of California, Davis
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP