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Synbiotics in Infants With Cyanotic Congenital Heart Disease

NCT01810978 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-05-09

No results posted yet for this study

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

Conditions

  • Congenital Heart Disease

Interventions

DIETARY_SUPPLEMENT

Bifidobacterium lactis plus inulin

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

DIETARY_SUPPLEMENT

Maltodextrin

same amount of maltodextrin per day will be given as placebo

Sponsors & Collaborators

  • Dr. Sami Ulus Children's Hospital

    lead OTHER

Principal Investigators

  • Banu Aydın, MD · MD

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-04-30
Completion
2013-05-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01810978 on ClinicalTrials.gov