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Bifidobacterium breve BBG-001 in very preterm infants: a randomised controlled phase 3 trial

Kate Costeloe1, Pollyanna Hardy2, Edmund Juszczak2

  • 1Centre for Paediatrics, Blizard Institute, Barts and the London School of Medicine and Dentistry, London, UK.

Lancet (London, England)
|December 3, 2015
PubMed

Insights

This study found that the probiotic Bifidobacterium breve BBG-001 did not significantly reduce necrotising enterocolitis, late-onset sepsis, or death in preterm infants. Therefore, routine use of this probiotic is not supported for prevention in very preterm infants.

Area of Science:

  • Neonatal research
  • Microbiome and infant health
  • Clinical trial methodology

Background:

  • Probiotics are investigated for their potential to reduce necrotising enterocolitis and late-onset sepsis in preterm infants.
  • Concerns exist regarding the rigor and generalizability of previous probiotic trials in neonates.
  • There is no established consensus on the routine use of probiotics for preterm infants.

Purpose of the Study:

  • To evaluate the effectiveness of the probiotic Bifidobacterium breve BBG-001 in reducing necrotising enterocolitis, late-onset sepsis, and mortality in preterm infants.
  • To provide robust evidence to inform clinical practice regarding probiotic supplementation in neonatal intensive care.

Main Methods:

  • A multicentre, randomised, controlled phase 3 trial (PiPS trial) involving infants born between 23 and 30 weeks' gestational age.
  • Randomised assignment (1:1) to receive either Bifidobacterium breve BBG-001 or a placebo (dilute infant formula).
  • Primary outcomes included necrotising enterocolitis (Bell stage 2 or 3), sepsis (blood culture positive >72h), and death before hospital discharge. Intention-to-treat analysis was performed.

Main Results:

  • No significant differences were observed in the rates of necrotising enterocolitis, sepsis, or death between the probiotic and placebo groups.
  • Necrotising enterocolitis occurred in 9% of the probiotic group vs. 10% of the placebo group (aRR 0.93).
  • Sepsis occurred in 11% of the probiotic group vs. 12% of the placebo group (aRR 0.97), and death occurred in 8% vs. 9% respectively (aRR 0.93). No adverse events were reported.

Conclusions:

  • The study found no evidence of benefit for Bifidobacterium breve BBG-001 in preventing necrotising enterocolitis and late-onset sepsis in very preterm infants.
  • The results do not support the routine administration of B. breve BBG-001 for this vulnerable population.
  • Further research may be needed to explore specific probiotic strains or different infant populations.
Abstract

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