Synbiotics in Infants With Cyanotic Congenital Heart Disease

Dr. Sami Ulus Children's Hospital

Status: Completed

Conditions: Congenital Heart Disease

Treatments: Dietary Supplement: Bifidobacterium lactis plus inulin; Dietary Supplement: Maltodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT01810978

128/01.10.2012

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 1 day to 3 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Bifidobacterium lactis plus inulin

Active Comparator group

Description:

Bifidobacterium lactis plus inulin

Treatment:

Dietary Supplement: Maltodextrin

maltodextrin

Placebo Comparator group

Description:

maltodextrin

Treatment:

Dietary Supplement: Bifidobacterium lactis plus inulin