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Probiotics in Infants With Cyanotic Congenital Heart Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of California, Davis.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Children's Miracle Network
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01018472
First received: November 19, 2009
Last updated: March 14, 2011
Last verified: March 2011

November 19, 2009
March 14, 2011
November 2009
February 2011   (final data collection date for primary outcome measure)
Fecal microbiota [ Time Frame: Weekly for 4 weeks then monthly ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01018472 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12
July 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
Both
up to 4 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01018472
200917427
Yes
Mark Underwood MD, UC Davis School of Medicine
University of California, Davis
Children's Miracle Network
Principal Investigator: Mark A. Underwood, MD UC Davis School of Medicine
University of California, Davis
March 2011

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