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Synbiotics in Infants With Cyanotic Congenital Heart Disease

Primary Purpose

Congenital Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bifidobacterium lactis plus inulin
Maltodextrin
Sponsored by
Dr. Sami Ulus Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congenital Heart Disease focused on measuring congenital heart disease, probiotic, prebiotic

Eligibility Criteria

1 Day - 3 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Sami Ulus CH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bifidobacterium lactis plus inulin

maltodextrin

Arm Description

Bifidobacterium lactis plus inulin

maltodextrin

Outcomes

Primary Outcome Measures

Sepsis

Secondary Outcome Measures

Necrotizing enterocolitis

Full Information

First Posted
March 12, 2013
Last Updated
May 7, 2013
Sponsor
Dr. Sami Ulus Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01810978
Brief Title
Synbiotics in Infants With Cyanotic Congenital Heart Disease
Official Title
Efficacy of Synbiotics in Infants With Cyanotic Congenital Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Sami Ulus Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
congenital heart disease, probiotic, prebiotic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bifidobacterium lactis plus inulin
Arm Type
Active Comparator
Arm Description
Bifidobacterium lactis plus inulin
Arm Title
maltodextrin
Arm Type
Placebo Comparator
Arm Description
maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Bifidobacterium lactis plus inulin
Intervention Description
5 billion unit Bifidobacterium lactis plus 900 mg inulin per day will be given
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
same amount of maltodextrin per day will be given as placebo
Primary Outcome Measure Information:
Title
Sepsis
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Necrotizing enterocolitis
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Banu Aydın, MD
Organizational Affiliation
MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sami Ulus CH
City
Ankara
ZIP/Postal Code
06120
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
21468216
Citation
Ellis CL, Rutledge JC, Underwood MA. Intestinal microbiota and blue baby syndrome: probiotic therapy for term neonates with cyanotic congenital heart disease. Gut Microbes. 2010 Nov-Dec;1(6):359-66. doi: 10.4161/gmic.1.6.14077.
Results Reference
result
PubMed Identifier
24043284
Citation
Dilli D, Aydin B, Zenciroglu A, Ozyazici E, Beken S, Okumus N. Treatment outcomes of infants with cyanotic congenital heart disease treated with synbiotics. Pediatrics. 2013 Oct;132(4):e932-8. doi: 10.1542/peds.2013-1262. Epub 2013 Sep 16.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/21468216
Description
http://www.ncbi.nlm.nih.gov/pubmed/21468216

Learn more about this trial

Synbiotics in Infants With Cyanotic Congenital Heart Disease

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