Effect of Saccharomyces Boulardii on Necrotizing Enterocolitis in Very Low Birth Weight Infants
NCT ID: NCT01315821
Last Updated: 2011-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
220 participants
INTERVENTIONAL
2011-02-28
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Saccharomyces boulardii
Saccharomyces boulardii 5 million unit/day for 3 months
Saccharomyces boulardii
5 million units/day for 3 months
control
Placebo- for 3 months
Placebo
Placebo for 3 months
Interventions
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Saccharomyces boulardii
5 million units/day for 3 months
Placebo
Placebo for 3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Not willing to participate
* Allergy to S. boulardii components
1 Day
2 Months
ALL
No
Sponsors
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Zekai Tahir Burak Women's Health Research and Education Hospital
OTHER
Responsible Party
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Zekai Tahir Burak Maternity Teaching Hospital
Principal Investigators
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Gamze Demirel, MD
Role: PRINCIPAL_INVESTIGATOR
Zekai Tahir Burak Women's Health Research and Education Hospital
Locations
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Zekai Tahir Burak Maternity Teaching Hospital
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Ugur Dilmen
Role: CONTACT
Facility Contacts
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Gamze Demirel
Role: primary
References
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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. 2023 Jul 26;7(7):CD005496. doi: 10.1002/14651858.CD005496.pub6.
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.
Other Identifiers
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1234
Identifier Type: -
Identifier Source: org_study_id
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