Comparison of Saccharomyces Boulardii and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
Information source: Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants
Intervention: Reflor (Dietary Supplement); mikostatin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Zekai Tahir Burak Women's Health Research and Education Hospital
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: Comparison of prophylactic S. boulardii and nystatin on candida colonization and infection in very low birth weight infants
Secondary outcome: Effect of S. boulardii on sepsis
Eligibility
Minimum age: N/A.
Maximum age: 90 Days.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Very low birth weight infants < 1500 gr
Exclusion Criteria:
- Genetic anomalies
- Not willing to participate
- Allergy to S. boulardii components
Locations and Contacts
Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology, Ankara 06230, Turkey; Recruiting Gamze Demirel, MD, Phone: +905324540156, Email: kgamze@hotmail.com Gamze Demirel, MD, Principal Investigator
Additional Information
Related publications: Chapman RL. Prevention and treatment of Candida infections in neonates. Semin Perinatol. 2007 Feb;31(1):39-46. Review. Murzyn A, Krasowska A, Stefanowicz P, Dziadkowiec D, Ćukaszewicz M. Capric acid secreted by S. boulardii inhibits C. albicans filamentous growth, adhesion and biofilm formation. PLoS One. 2010 Aug 10;5(8):e12050. doi: 10.1371/journal.pone.0012050.
Starting date: July 2011
Last updated: August 5, 2011
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