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NCT01810978 Clinical Trial

Synbiotics in Infants With Cyanotic Congenital Heart Disease

Congenital Heart Disease Clinical Trial

Official title:
Efficacy of Synbiotics in Infants With Cyanotic Congenital Heart Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01810978
Other study ID # 128/01.10.2012
Secondary ID
Status Completed
Phase N/A
First received March 12, 2013
Last updated May 7, 2013
Start date October 2012
Est. completion date May 2013

Study information
Verified date May 2013
Source Dr. Sami Ulus Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date May 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender All
Age group N/A to 3 Months
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Bifidobacterium lactis plus inulin
5 billion unit Bifidobacterium lactis plus 900 mg inulin per day will be given
• Maltodextrin
same amount of maltodextrin per day will be given as placebo

Locations
Country Name City State
Turkey Sami Ulus CH Ankara

Sponsors (1)
Lead Sponsor Collaborator
Dr. Sami Ulus Children's Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Sepsis 8 weeks
Secondary Necrotizing enterocolitis 8 weeks
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