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

Phase 3

Completed

• Conditions: Necrotizing Enterocolitis; Very Low Birth Weight Infants
• Interventions: Drug: Placebo; Drug: Lactobacillus reuteri

• Registration Number: NCT01531179
• 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-04
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-10
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Last Update Submitted: 2013-05-08
• Last Update Posted: 2013-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Very low birth weight infants < 1500 gr
• Gestational age < 32 weeks

Exclusion Criteria

• Genetic anomalies
• Short bowel syndrome
• Not willing to participate
• Allergy to Lactobacillus reuteri components

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Placebo for 3 months
Lactobacillus reuteri	Lactobacillus reuteri	Lactobacillus reuteri 100 million CFU/day for 3 months

Primary Outcome Measures

Name	Time	Method
Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants	up to 6 months	NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group.

Secondary Outcome Measures

Name	Time	Method
Effect of Lactobacillus reuteri on culture proved sepsis	up to 6 months	Patients with culture positivity will accept as proven sepsis.
Effect of Lactobacillus reuteri on weight gain	up to 6 months	The infants will be weight daily on scales that will calibrated weekly.
Effect of Lactobacillus reuteri on length of hospital stay	up to 6 months	Specified length of hospital stay as days

Trial Locations

Locations (1)

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