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 Hospital

Status and phase: Unknown; Phase 4

Conditions: Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants

Treatments: Dietary Supplement: Reflor; Drug: mikostatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01411748

demirel98

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 1 to 90 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Very low birth weight infants < 1500 gr

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

S. boulardii

Experimental group

Description:

The patients in this group will be given 5 million unit/day S. boulardii until discharge.

Treatment:

Dietary Supplement: Reflor

nystatin

Active Comparator group

Treatment:

Drug: mikostatin