Synbiotics in Infants With Cyanotic Congenital Heart Disease

Not Applicable

Completed

• Conditions: Congenital Heart Disease
• Interventions: Dietary Supplement: Maltodextrin; Dietary Supplement: Bifidobacterium lactis plus inulin

• Registration Number: NCT01810978
• Lead Sponsor: Dr. Sami Ulus Children's Hospital

Brief 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

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-14
• Primary Completion: 2013-04
• Status Verified: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-07
• Last Update Posted: 2013-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bifidobacterium lactis plus inulin	Maltodextrin	Bifidobacterium lactis plus inulin
maltodextrin	Bifidobacterium lactis plus inulin	maltodextrin

Primary Outcome Measures

Name	Time	Method
Sepsis	8 weeks

Secondary Outcome Measures

Name	Time	Method
Necrotizing enterocolitis	8 weeks

Trial Locations

Locations (1)

Sami Ulus CH; 🇹🇷 Ankara, Turkey