Probiotics in Infants With Cyanotic Congenital Heart Disease

• Sponsor: University of California, Davis (Other)
• Overall Status: Completed
• CT.gov ID: NCT01018472
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• 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: Nov 1, 2009
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Fecal microbiota [Weekly for 4 weeks then monthly]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 4 Months
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Davis Children's Hospital	Sacramento	California	United States	95817

Sponsors and Collaborators

• University of California, Davis

Investigators

• Principal Investigator: Mark A. Underwood, MD, UC Davis School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT01018472
• Other Study ID Numbers: 200917427
• First Posted: Nov 23, 2009
• Last Update Posted: Dec 2, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by University of California, Davis: cyanotic heart disease; congenital heart disease; intestinal microbiota; probiotics
• Additional relevant MeSH terms: Heart Diseases; Heart Defects, Congenital

Study Results

No Results Posted as of Dec 2, 2014