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

Necrotizing Enterocolitis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01315821
Study type Interventional
Source Zekai Tahir Burak Women's Health Research and Education Hospital
Contact Gamze Demirel, MD
Phone +903123065270
Email kgamze@hotmail.com
Status Recruiting
Phase Phase 3
Start date February 2011
Completion date December 2011
View Details
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