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Comparison of Saccharomyces Boulardii and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants

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ClinicalTrials.gov Identifier: NCT01411748
Recruitment Status : Unknown
Verified July 2011 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was:  Recruiting
First Posted : August 8, 2011
Last Update Posted : August 8, 2011
Sponsor:
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital

Study Description
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Brief Summary:
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Saccharomyces boulardii was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic S boulardii in reducing the candida colonization and infection in very low birth weight infants.

Condition or disease Intervention/treatment Phase
Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants Dietary Supplement: Reflor Drug: mikostatin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Study Start Date : July 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: S. boulardii
The patients in this group will be given 5 million unit/day S. boulardii until discharge.
 Dietary Supplement: Reflor
5 million unit/day, orally, beginning on the second day of life, until discharge from hospital
Active Comparator: nystatin Drug: mikostatin
50000 unit/3 times a day, both for orally and by orogastric route


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of prophylactic S. boulardii and nystatin on candida colonization and infection in very low birth weight infants [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Effect of S. boulardii on sepsis [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   up to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Very low birth weight infants < 1500 gr

Exclusion Criteria:

  • Genetic anomalies
  • Not willing to participate
  • Allergy to S. boulardii components
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411748


Locations
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Turkey
Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology Recruiting
Ankara, Turkey, 06230
Contact: Gamze Demirel, MD    +905324540156    kgamze@hotmail.com   
Principal Investigator: Gamze Demirel, MD         
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
More Information
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Publications:

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Responsible Party: Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01411748    
Other Study ID Numbers: demirel98
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: August 8, 2011
Last Verified: July 2011
Additional relevant MeSH terms:
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Birth Weight
Body Weight