Effect of Saccharomyces Boulardii on Necrotizing Enterocolitis in Very Low Birth Weight Infants
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Zekai Tahir Burak Maternity and Teaching Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Zekai Tahir Burak Maternity and Teaching Hospital
Information provided by:
Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01315821
First received: February 24, 2011
Last updated: August 4, 2011
Last verified: February 2011
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| First Received Date ICMJE | February 24, 2011 | ||||||||
| Last Updated Date | August 4, 2011 | ||||||||
| Start Date ICMJE | February 2011 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants [ Time Frame: up to 6 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01315821 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Saccharomyces Boulardii on Necrotizing Enterocolitis in Very Low Birth Weight Infants | ||||||||
| Official Title ICMJE | Role Of Saccharomyces Boulardii in Preventin Necrotizing Enterocolitis in Very Low Birth Weight Infants | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 220 | ||||||||
| Estimated Completion Date | December 2011 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 2 Months | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Turkey | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01315821 | ||||||||
| Other Study ID Numbers ICMJE | 1234 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Zekai Tahir Burak Maternity Teaching Hospital | ||||||||
| Study Sponsor ICMJE | Zekai Tahir Burak Maternity and Teaching Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Zekai Tahir Burak Maternity and Teaching Hospital | ||||||||
| Verification Date | February 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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