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

Zekai Tahir Burak Women's Health Research and Education Hospital140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

140

Conditions

Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants

Interventions

Reflor

5 million unit/day, orally, beginning on the second day of life, until discharge from hospital

mikostatinDRUG

50000 unit/3 times a day, both for orally and by orogastric route

Eligibility

Sex: ALLMin age: 1 DayMax age: 90 Days

Medical Language ↔ Plain English

Inclusion Criteria: * Very low birth weight infants \< 1500 gr Exclusion Criteria: * Genetic anomalies * Not willing to participate * Allergy to S. boulardii components

Locations (1)

Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology

Ankara, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

Comparison of prophylactic S. boulardii and nystatin on candida colonization and infection in very low birth weight infants

Time frame: 6 months

Secondary Outcomes

Effect of S. boulardii on sepsis

Time frame: 6 months

Data from ClinicalTrials.gov

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