Probiotics in Infants With Cyanotic Congenital Heart Disease

Cyanotic Congenital Heart Disease Clinical Trial

Official title:

Probiotics in Infants With Cyanotic Congenital Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018472
• Other study ID #: 200917427
• Status: Completed
• Phase: N/A
• First received: November 19, 2009
• Last updated: December 1, 2014
• Start date: November 2009
• Est. completion date: December 2011

Study information

• Verified date: December 2014
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Months

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Cyanotic Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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)

Locations

Country	Name	City	State
United States	UC Davis Children's Hospital	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal microbiota		Weekly for 4 weeks then monthly	No