Skip to main content
OpenTrials
Completed

NCT Number: NCT01810978

Synbiotics in Infants With Cyanotic Congenital Heart Disease

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

1 day–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sami Ulus CH

Ankara, 06120, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bifidobacterium lactis plus inulin

Dietary Supplement

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

Maltodextrin

Dietary Supplement

same amount of maltodextrin per day will be given as placebo

Primary outcomes

  1. Sepsis

    Time frame: 8 weeks

Secondary outcomes

  1. Necrotizing enterocolitis

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Dr. Sami Ulus Children's Hospital

Other

Registry information

Official study title

Efficacy of Synbiotics in Infants With Cyanotic Congenital Heart Disease

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 14, 2013
Registry last updated
May 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.