NCT01340469

Effect of Oral Probiotic Supplementation on The Rate of Hospital Acquired Infection and Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants

Nosocomial Infections and Necrotizing Enterocolitis in Preterm Neonates Treated With Lactobacillus Acidophilus and Bifidobacterium Infantis in An Intensive Care Unit : A Randomized Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: King Chulalongkorn Memorial Hospital · Academic / Other
• Sex: All
• Age: 3 Days – 28 Days
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether oral probiotic supplementation could reduce the incidence of nosocomial infections in preterm infants.

Detailed description

There are growing numbers of evidence indicating the beneficial effects of normal enteric flora (probiotics) with regard to the host defense against infection. In vitro and in vivo studies have shown that probiotics such as lactobacilli and bifidobacteria have inhibitory effects on other pathogenic bacteria.This evidence, along with the results of recent clinical studies, has demonstrated the beneficial effects of probiotics in the prevention of NEC in VLBW infants.However, most of the studies reported nosocomial infection as a secondary outcome and the findings were controversial regarding probiotics efficacy in preventing nosocomial infections. There is only one study that was aimed to investigate effects of probiotic on the incidence of nosocomial infection. Given the potential benefit of probiotics against infection and the lack of clinical studies in this regard, we conducted a randomized clinical trial to determine whether probiotic supplementation (in the form of Lactobacillus acidophilus and Bifidobacterium infantis) could reduce nosocomial infection rate among preterm VLBW infants in a intensive care nursery setting.

Conditions

• Nosocomial Infection
• Necrotizing Enterocolitis

Interventions

Type	Name	Description
BIOLOGICAL	probiotics	Daily enteral probiotic supplementation (live Lactobacillus acidophilus and Bifidobacterium infantis) at a dose of 2.5 x 108 CFU of each strain once a day.The supplementation was started on the first day of enteral feeding and continued for at least 28 days or until discharge. The study drug was in liquid form and mixed with breast milk or formula before given to the infants. The preparation was made on a daily basis by one person who was not involved in the care of the infants.

Timeline

• Start date: 2005-01-01
• Primary completion: 2008-03-01
• Completion: 2008-06-01
• First posted: 2011-04-22
• Last updated: 2011-04-22

Locations

1 site across 1 country: Thailand