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Synbiotics in Infants With Cyanotic Congenital Heart Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dilek Dilli, Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier:
NCT01810978
First received: March 12, 2013
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Congenital Heart Disease
Dietary Supplement: Bifidobacterium lactis plus inulin
Dietary Supplement: Maltodextrin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Synbiotics in Infants With Cyanotic Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Dr. Sami Ulus Children's Hospital:

Primary Outcome Measures:
  • Sepsis [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Necrotizing enterocolitis [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2012
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bifidobacterium lactis plus inulin
Bifidobacterium lactis plus inulin
Dietary Supplement: Maltodextrin
same amount of maltodextrin per day will be given as placebo
Placebo Comparator: maltodextrin
maltodextrin
Dietary Supplement: Bifidobacterium lactis plus inulin
5 billion unit Bifidobacterium lactis plus 900 mg inulin per day will be given

Detailed 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

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01810978

Locations
Turkey
Sami Ulus CH
Ankara, Turkey, 06120
Sponsors and Collaborators
Dr. Sami Ulus Children's Hospital
Investigators
Principal Investigator: Banu Aydın, MD MD
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dilek Dilli, Assoc Prof, Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier: NCT01810978     History of Changes
Other Study ID Numbers: 128/01.10.2012
Study First Received: March 12, 2013
Last Updated: May 7, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by Dr. Sami Ulus Children's Hospital:
congenital heart disease, probiotic, prebiotic

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on November 20, 2014