MedDataX Logo

Probiotics in Infants With Cyanotic Congenital Heart Disease

NCT ID: NCT01018472

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cyanotic Congenital Heart Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bifidobacterium infantis

Group Type EXPERIMENTAL

Bifidobacterium infantis

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bifidobacterium infantis

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mark A. Underwood, MD

Role: PRINCIPAL_INVESTIGATOR

UC Davis School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UC Davis Children's Hospital

Sacramento, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

200917427

Identifier Type: -

Identifier Source: org_study_id