Back to resultsEffect of Saccharomyces Boulardii on Necrotizing Enterocolitis in Very Low Birth Weight Infants
Primary Purpose
Necrotizing Enterocolitis, Very Low Birth Weight Infants
Status
Unknown status
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
Saccharomyces boulardii
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Necrotizing Enterocolitis focused on measuring Saccharomyces boulardii, necrotizing enterocolitis
Eligibility Criteria
Inclusion Criteria:
- Very low birth weight infants < 1500 gr
Exclusion Criteria:
- Genetic anomalies
- Not willing to participate
- Allergy to S. boulardii components
Sites / Locations
- Zekai Tahir Burak Maternity Teaching HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Saccharomyces boulardii
control
Arm Description
Saccharomyces boulardii 5 million unit/day for 3 months
Placebo- for 3 months
Outcomes
Primary Outcome Measures
Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants
Secondary Outcome Measures
Effect of Saccharomyces boulardii on culture proved sepsis
Effect of Saccharomyces boulardii on weight gain
Effect of Saccharomyces boulardii on length of hospital stay
Effect of Saccharomyces boulardii on mortality
Full Information
NCT ID
NCT01315821
First Posted
February 24, 2011
Last Updated
August 4, 2011
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01315821
Brief Title
Effect of Saccharomyces Boulardii on Necrotizing Enterocolitis in Very Low Birth Weight Infants
Official Title
Role Of Saccharomyces Boulardii in Preventin Necrotizing Enterocolitis in Very Low Birth Weight Infants
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are < 1500 gr. Although bifidobacterium and lactobacilli sp. have been used to reduce the incidence of NEC in clinical trials, Saccharomyces boulardii has not been used in the prevention of NEC in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.
Detailed Description
The primary outcome of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Enterocolitis, Very Low Birth Weight Infants
Keywords
Saccharomyces boulardii, necrotizing enterocolitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Saccharomyces boulardii
Arm Type
Experimental
Arm Description
Saccharomyces boulardii 5 million unit/day for 3 months
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Placebo- for 3 months
Intervention Type
Drug
Intervention Name(s)
Saccharomyces boulardii
Other Intervention Name(s)
Reflor
Intervention Description
5 million units/day for 3 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for 3 months
Primary Outcome Measure Information:
Title
Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Effect of Saccharomyces boulardii on culture proved sepsis
Time Frame
6 months
Title
Effect of Saccharomyces boulardii on weight gain
Time Frame
up to 6 months
Title
Effect of Saccharomyces boulardii on length of hospital stay
Time Frame
up to 6 months
Title
Effect of Saccharomyces boulardii on mortality
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Very low birth weight infants < 1500 gr
Exclusion Criteria:
Genetic anomalies
Not willing to participate
Allergy to S. boulardii components
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gamze Demirel, MD
Phone
+903123065270
Email
kgamze@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ugur Dilmen
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamze Demirel, MD
Organizational Affiliation
Zekai Tahir Burak Women's Health Research and Education Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zekai Tahir Burak Maternity Teaching Hospital
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gamze Demirel
First Name & Middle Initial & Last Name & Degree
Gamze Demirel, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
33058137
Citation
Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5.
Results Reference
derived
Learn more about this trial
Effect of Saccharomyces Boulardii on Necrotizing Enterocolitis in Very Low Birth Weight Infants
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