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NCT01411748 Clinical Trial

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

Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01411748
Other study ID # demirel98
Secondary ID
Status Recruiting
Phase Phase 4
First received August 5, 2011
Last updated August 5, 2011
Start date July 2011
Est. completion date December 2011

Study information
Verified date July 2011
Source Zekai Tahir Burak Women's Health Research and Education Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 140
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 90 Days
Eligibility Inclusion Criteria:

- Very low birth weight infants < 1500 gr

Exclusion Criteria:

- Genetic anomalies

- Not willing to participate

- Allergy to S. boulardii components

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

  • Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants
  • Birth Weight

Intervention

Dietary Supplement:
• Reflor
5 million unit/day, orally, beginning on the second day of life, until discharge from hospital
Drug:
• mikostatin
50000 unit/3 times a day, both for orally and by orogastric route

Locations
Country Name City State
Turkey Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology Ankara

Sponsors (1)
Lead Sponsor Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Chapman RL. Prevention and treatment of Candida infections in neonates. Semin Perinatol. 2007 Feb;31(1):39-46. Review. — View Citation

Murzyn A, Krasowska A, Stefanowicz P, Dziadkowiec D, Lukaszewicz 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of prophylactic S. boulardii and nystatin on candida colonization and infection in very low birth weight infants 6 months Yes
Secondary Effect of S. boulardii on sepsis 6 months Yes