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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier:
NCT01411748
First received: August 5, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted

August 5, 2011
August 5, 2011
July 2011
December 2011   (final data collection date for primary outcome measure)
Comparison of prophylactic S. boulardii and nystatin on candida colonization and infection in very low birth weight infants [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Effect of S. boulardii on sepsis [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparison of Saccharomyces Boulardii and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants
  • 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
  • Experimental: S. boulardii
    The patients in this group will be given 5 million unit/day S. boulardii until discharge.
    Intervention: Dietary Supplement: Reflor
  • Active Comparator: nystatin
    Intervention: Drug: mikostatin
Chapman RL. Prevention and treatment of Candida infections in neonates. Semin Perinatol. 2007 Feb;31(1):39-46. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Very low birth weight infants < 1500 gr

Exclusion Criteria:

  • Genetic anomalies
  • Not willing to participate
  • Allergy to S. boulardii components
Both
up to 90 Days
No
Turkey
 
NCT01411748
demirel98
Yes
Zekai Tahir Burak Maternity and Teaching Hospital
Zekai Tahir Burak Women's Health Research and Education Hospital
Not Provided
Not Provided
Zekai Tahir Burak Women's Health Research and Education Hospital
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP