Cyanotic Congenital Heart DiseaseNCT01018472
Probiotics in Infants With Cyanotic Congenital Heart Disease
A study testing Bifidobacterium infantis in people with Cyanotic Congenital Heart Disease, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Cyanotic Congenital Heart Disease
- What is being tested?
- Bifidobacterium infantis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cyanotic congenital heart disease
- Term infant
- Born at or transferred to UC Davis Children's hospital
Who cannot join
- Congenital anomalies of the intestinal tract
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Children's Hospital
Sacramento, California, 95817
About this study
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.
Read the 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.
- Conditions
- Cyanotic Congenital Heart Disease
- Being tested
- Bifidobacterium infantis, Placebo
- Keywords
- cyanotic heart disease, congenital heart disease, intestinal microbiota, probiotics
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium infantisDietary supplement
1 billion organisms twice daily either through a feeding tube or by mouth for 4 months
PlaceboOther
A dilute preparation of pregestimil formula (similar in appearance to the probiotic product)
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium infantis | Experimental | Not described Receives: Dietary Supplement: Bifidobacterium infantis |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal microbiota
Measured: Weekly for 4 weeks then monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyanotic Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark A. Underwood, MD, Principal investigator, UC Davis School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018472
- Sponsor's protocol ID
- 200917427
- Status last verified
- Dec 2014
- First submitted
- 19 Nov 2009
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics in Infants With Cyanotic Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT01018472
- Acronym / sponsor ID
- 200917427
- Conditions
- Cyanotic Congenital Heart Disease
- Keywords
- cyanotic heart disease, congenital heart disease, intestinal microbiota, probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium infantis | Experimental | Dietary Supplement: Bifidobacterium infantis |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Cyanotic congenital heart disease
- Term infant
- Born at or transferred to UC Davis Children's hospital
Key exclusion criteria (1 listed)
- Congenital anomalies of the intestinal tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium infantis1 billion organisms twice daily either through a feeding tube or by mouth for 4 months | Dietary supplement | Bifidobacterium infantis |
| PlaceboA dilute preparation of pregestimil formula (similar in appearance to the probiotic product) | Other | Placebo |
Primary outcome
Fecal microbiota
Time frame: Weekly for 4 weeks then monthly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A. Underwood, MD principal investigator
UC Davis School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium infantis in people with Cyanotic Congenital Heart Disease, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal microbiota (time frame: Weekly for 4 weeks then monthly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.