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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


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


Minimum age: N/A. Maximum age: 90 Days. Gender(s): Both.


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, Ɓukaszewicz 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

Page last updated: August 23, 2015

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