- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01810978
Synbiotics in Infants With Cyanotic Congenital Heart Disease
May 7, 2013 updated by: Dilek Dilli, Dr. Sami Ulus Children's Hospital
Efficacy of Synbiotics in Infants With Cyanotic Congenital Heart Disease
Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants.
The investigators hypothesized that synbiotics may reduce the rate of sepsis and necrotizing enterocolitis in infants with CHD
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants.
Probiotics may prevent pathogen colonization in infants with CHD.
Therefore, the investigators hypothesized that synbiotics may reduce the rate of sepsis and necrotizing enterocolitis in infants with CHD
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey, 06120
- Sami Ulus CH
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 3 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cyanotic congenital heart disease
- infants >35 weeks of gestational age
- Born at or transferred to Sami Ulus CH
Exclusion Criteria:
- Congenital anomalies of the intestinal tract
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bifidobacterium lactis plus inulin
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same amount of maltodextrin per day will be given as placebo
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Placebo Comparator: maltodextrin
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5 billion unit Bifidobacterium lactis plus 900 mg inulin per day will be given
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sepsis
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Necrotizing enterocolitis
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Banu Aydın, MD, MD
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ellis CL, Rutledge JC, Underwood MA. Intestinal microbiota and blue baby syndrome: probiotic therapy for term neonates with cyanotic congenital heart disease. Gut Microbes. 2010 Nov-Dec;1(6):359-66. doi: 10.4161/gmic.1.6.14077.
- Dilli D, Aydin B, Zenciroglu A, Ozyazici E, Beken S, Okumus N. Treatment outcomes of infants with cyanotic congenital heart disease treated with synbiotics. Pediatrics. 2013 Oct;132(4):e932-8. doi: 10.1542/peds.2013-1262. Epub 2013 Sep 16.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
March 12, 2013
First Submitted That Met QC Criteria
March 13, 2013
First Posted (Estimate)
March 14, 2013
Study Record Updates
Last Update Posted (Estimate)
May 9, 2013
Last Update Submitted That Met QC Criteria
May 7, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 128/01.10.2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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