NCT01315821

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

Role Of Saccharomyces Boulardii in Preventin Necrotizing Enterocolitis in Very Low Birth Weight Infants

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 2 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Necrotizing Enterocolitis
• Very Low Birth Weight Infants

Interventions

Type	Name	Description
DRUG	Saccharomyces boulardii	5 million units/day for 3 months
DRUG	Placebo	Placebo for 3 months

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-03-15
• Last updated: 2011-08-08

Locations

1 site across 1 country: Turkey (Türkiye)