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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01411748

Enrollment

140

Registered

2011-08-08

Start date

2011-07-31

Completion date

2011-12-31

Last updated

2011-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants

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.

Interventions

DIETARY_SUPPLEMENTReflor

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

DRUGmikostatin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Days to 90 Days

Healthy volunteers

Inclusion criteria

* Very low birth weight infants \< 1500 gr

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Effect of S. boulardii on sepsis	6 months

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026