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

NCT01531179 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2013-05-13

No results posted yet for this study

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

DRUG

Lactobacillus reuteri

Lactobacillus reuteri 100 million CFU/day for 3 months

DRUG

Placebo

Placebo for 3 months

Sponsors & Collaborators

  • Zekai Tahir Burak Women's Health Research and Education Hospital

    lead OTHER

Principal Investigators

  • Mehmet Yekta Oncel, MD · Neonatology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01531179 on ClinicalTrials.gov