ClinicalTrials.Veeva

Menu

Synbiotics in Infants With Cyanotic Congenital Heart Disease

D

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems