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
  Purpose

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 Intervention
Cyanotic Congenital Heart Disease
Dietary Supplement: Bifidobacterium infantis
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Probiotics in Infants With Cyanotic Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Fecal microbiota [ Time Frame: Weekly for 4 weeks then monthly ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: November 2009
Estimated Study Completion Date: July 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   up to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018472

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

No publications provided

Responsible Party: Mark Underwood MD, UC Davis School of Medicine
ClinicalTrials.gov Identifier: NCT01018472     History of Changes
Other Study ID Numbers: 200917427
Study First Received: November 19, 2009
Last Updated: March 14, 2011
Health Authority: United States: Institutional Review Board

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
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 19, 2014