NCT01531179

Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis in Very Low-birth Weight Infants

Role Of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis in Very Low Birth Weight Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 6 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 g. Although bifidobacterium and other lactobacilli spp. have been used to reduce the incidence of necrotizing enterocolitis in clinical trials, Lactobacillus reuteri has not been used in the prevention of necrotizing enterocolitis in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered Lactobacillus reuteri in reducing the incidence and severity of necrotizing enterocolitis in very low birth weight infants.

Conditions

• Necrotizing Enterocolitis
• Very Low Birth Weight Infants

Interventions

Type	Name	Description
DRUG	Lactobacillus reuteri	Lactobacillus reuteri 100 million CFU/day for 3 months
DRUG	Placebo	Placebo for 3 months

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-02-10
• Last updated: 2013-05-13

Locations

1 site across 1 country: Turkey (Türkiye)