Effect of Saccharomyces Boulardii on Necrotizing Enterocolitis in Very Low Birth Weight Infants

Phase 3

• Conditions: Necrotizing Enterocolitis; Very Low Birth Weight Infants
• Interventions: Drug: Saccharomyces boulardii; Drug: Placebo

• Registration Number: NCT01315821
• 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. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are \< 1500 gr. Although bifidobacterium and lactobacilli sp. have been used to reduce the incidence of NEC in clinical trials, Saccharomyces boulardii has not been used in the prevention of NEC in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.

Detailed Description

The primary outcome of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.

Study Timeline

• Status Verified: 2011-02
• Study Start: 2011-02
• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Last Update Submitted: 2011-08-04
• Last Update Posted: 2011-08-08
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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
Saccharomyces boulardii	Saccharomyces boulardii	Saccharomyces boulardii 5 million unit/day for 3 months
control	Placebo	Placebo- for 3 months

Primary Outcome Measures

Name	Time	Method
Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants	up to 6 months

Secondary Outcome Measures

Name	Time	Method
Effect of Saccharomyces boulardii on weight gain	up to 6 months
Effect of Saccharomyces boulardii on length of hospital stay	up to 6 months
Effect of Saccharomyces boulardii on mortality	up to 6 months
Effect of Saccharomyces boulardii on culture proved sepsis	6 months

Trial Locations

Locations (1)

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