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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01315821 |
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Date of registration:
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24/02/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Saccharomyces Boulardii on Necrotizing Enterocolitis in Very Low Birth Weight Infants
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Scientific title:
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Role Of Saccharomyces Boulardii in Preventin Necrotizing Enterocolitis in Very Low Birth Weight Infants |
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Date of first enrolment:
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February 2011 |
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Target sample size:
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220 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01315821 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Gamze Demirel |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Gamze Demirel, MD |
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Address:
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Telephone:
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+903123065270 |
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Email:
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kgamze@hotmail.com |
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Affiliation:
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Name:
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Gamze Demirel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Zekai Tahir Burak Women's Health Research and Education Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Very low birth weight infants < 1500 gr
Exclusion Criteria:
- Genetic anomalies
- Not willing to participate
- Allergy to S. boulardii components
Age minimum:
N/A
Age maximum:
2 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Necrotizing Enterocolitis
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Very Low Birth Weight Infants
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Intervention(s)
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Drug: Placebo
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Drug: Saccharomyces boulardii
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Primary Outcome(s)
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Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants
[Time Frame: up to 6 months]
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Secondary Outcome(s)
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Effect of Saccharomyces boulardii on weight gain
[Time Frame: up to 6 months]
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Effect of Saccharomyces boulardii on culture proved sepsis
[Time Frame: 6 months]
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Effect of Saccharomyces boulardii on mortality
[Time Frame: up to 6 months]
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Effect of Saccharomyces boulardii on length of hospital stay
[Time Frame: up to 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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