NCT01018472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

1.3 years

First QC Date

November 19, 2009

Last Update Submit

December 1, 2014

Conditions

Cyanotic Congenital Heart Disease

Keywords

cyanotic heart diseasecongenital heart diseaseintestinal microbiotaprobiotics

Outcome Measures

Primary Outcomes (1)

  • Fecal microbiota

    Weekly for 4 weeks then monthly

Study Arms (2)

Bifidobacterium infantis

EXPERIMENTAL
Dietary Supplement: Bifidobacterium infantis

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Bifidobacterium infantisDIETARY_SUPPLEMENT

1 billion organisms twice daily either through a feeding tube or by mouth for 4 months

Bifidobacterium infantis
PlaceboOTHER

A dilute preparation of pregestimil formula (similar in appearance to the probiotic product)

Placebo

Eligibility Criteria

AgeUp to 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Cyanotic congenital heart disease
  • Term infant
  • Born at or transferred to UC Davis Children's hospital

You may not qualify if:

  • Congenital anomalies of the intestinal tract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Children's Hospital

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mark A. Underwood, MD

    UC Davis School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2009

First Posted

November 23, 2009

Study Start

November 1, 2009

Primary Completion

February 1, 2011

Study Completion

December 1, 2011

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations

US(1)