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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

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.

Condition or disease Intervention/treatment Phase
Cyanotic Congenital Heart Disease Dietary Supplement: Bifidobacterium infantis Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Probiotics in Infants With Cyanotic Congenital Heart Disease
Study Start Date : November 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Experimental: Bifidobacterium infantis Dietary Supplement: Bifidobacterium infantis
1 billion organisms twice daily either through a feeding tube or by mouth for 4 months

Placebo Comparator: Placebo Other: Placebo
A dilute preparation of pregestimil formula (similar in appearance to the probiotic product)

Primary Outcome Measures :
  1. Fecal microbiota [ Time Frame: Weekly for 4 weeks then monthly ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01018472

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United States, California
UC Davis Children's Hospital
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
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Principal Investigator: Mark A. Underwood, MD UC Davis School of Medicine

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Responsible Party: University of California, Davis Identifier: NCT01018472     History of Changes
Other Study ID Numbers: 200917427
First Posted: November 23, 2009    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by University of California, Davis:
cyanotic heart disease
congenital heart disease
intestinal microbiota

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities