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

Phase 4

• Conditions: Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants
• Interventions: Drug: mikostatin; Dietary Supplement: Reflor

• Registration Number: NCT01411748
• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-07
• Study Start: 2011-07
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-05
• Last Update Submitted: 2011-08-05
• Study First Posted: 2011-08-08
• Last Update Posted: 2011-08-08
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Very low birth weight infants < 1500 gr

Exclusion Criteria

• Genetic anomalies
• Not willing to participate
• Allergy to S. boulardii components

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nystatin	mikostatin	-
S. boulardii	Reflor	The patients in this group will be given 5 million unit/day S. boulardii until discharge.

Primary Outcome Measures

Name	Time	Method
Comparison of prophylactic S. boulardii and nystatin on candida colonization and infection in very low birth weight infants	6 months

Secondary Outcome Measures

Name	Time	Method
Effect of S. boulardii on sepsis	6 months

Trial Locations

Locations (1)

Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology; 🇹🇷 Ankara, Turkey