Synbiotics in Infants With Cyanotic Congenital Heart Disease

Dr. Sami Ulus Children's Hospital100 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

100

Conditions

Congenital Heart Disease

Interventions

Bifidobacterium lactis plus inulinDIETARY_SUPPLEMENT

5 billion unit Bifidobacterium lactis plus 900 mg inulin per day will be given

MaltodextrinDIETARY_SUPPLEMENT

same amount of maltodextrin per day will be given as placebo

Eligibility

Sex: ALLMin age: 1 DayMax age: 3 Months

Medical Language ↔ Plain English

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

Locations (1)

Sami Ulus CH

Ankara, Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

Sepsis

Time frame: 8 weeks

Secondary Outcomes

Necrotizing enterocolitis

Time frame: 8 weeks

Data from ClinicalTrials.gov

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