PLoS ONE (Jan 2014)

Effect of Bifidobacterium breve M-16V supplementation on fecal bifidobacteria in preterm neonates--a randomised double blind placebo controlled trial.

  • Sanjay Patole,
  • Anthony D Keil,
  • Annie Chang,
  • Elizabeth Nathan,
  • Dorota Doherty,
  • Karen Simmer,
  • Meera Esvaran,
  • Patricia Conway

DOI
https://doi.org/10.1371/journal.pone.0089511
Journal volume & issue
Vol. 9, no. 3
p. e89511

Abstract

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BackgroundProbiotic supplementation significantly reduces the risk of necrotising enterocolitis (NEC) and all cause mortality in preterm neonates. Independent quality assessment is important before introducing routine probiotic supplementation in this cohort.AimTo assess product quality, and confirm that Bifidobacterium breve (B. breve) M-16V supplementation will increase fecal B. breve counts without adverse effects.Methods and participantsStrain identity (16S rRNA gene sequencing), viability over 2 year shelf-life were confirmed, and microbial contamination of the product was ruled out. In a controlled trial preterm neonates (Gestation ResultsA total of 159 neonates (Probiotic: 79, Placebo: 80) were enrolled. Maternal and neonatal demographic characteristics were comparable between the groups. The proportion of neonates with detectable B. breve increased significantly post intervention: Placebo: [S1:2/66 (3%), S2: 25/66 (38%), pConclusionB. breve M-16V is a suitable probiotic strain for routine use in preterm neonates.Trial registrationAustralia New Zealand Clinical Trial Registry ACTRN 12609000374268.