Impact of a multi-strain probiotic on healthcare-associated bloodstream infection incidence and severity in preterm neonates

INTRODUCTION: Hospital acquired bloodstream infection (HA-BSI) is a major contributor to morbidity and mortality in preterm, very low birthweight infants, especially in low-to-middle- income countries (LMIC).
METHODS: We conducted a double-blind, placebo-controlled, randomized clinical trial to investigate the effect of a multi-strain probiotic formulation (LabinicTM) on the incidence and severity of HA-BSI in preterm neonates.
RESULTS: Two hundred neonates (100 per arm) were included in the trial. Fifteen neonates developed HA-BSI events (2 in the probiotic arm and 13 in the placebo arm). The median day of life at HA-BSI onset for the probiotic group was 10.5 ±3.54, and placebo group was 11.15 ±6.37. The incidence of HA-BSI in neonates receiving the probiotic was significantly lower compared to those receiving the placebo (0.93 versus 5.99 HA-BSI events/1000 neonate-days; incidence rate ratio (IRR) of 0.156 [95% CI: 0.017 to 0.691], p = 0.0046). Calculating the incidence rate per 1000 neonate-days, the incidence of sepsis/death events was 2.34 in the probiotic, and 6.45 in the placebo group. The IRR of probiotic relative to placebo sepsis/death events was 0.33 (95% CI: 0.11 to 0.97), p =0.043.
DISCUSSION AND CONCLUSION: The use of a multi strain probiotic shows great potential as a cost effective, very low side-effect method of reducing HA-BSI and subsequent mortality in preterm neonates. Multi-strain probiotics (through reduction in HA-BSI events) could potentially reduce the length of hospital stay in preterm neonates and thus be a resource and cost saving intervention. This study showed that a multi-strain probiotic (Lactobacillus acidophilus, Bifidobacterium bifidum and Bifidobacterium infantis) has the potential the reduce HA-BSI, morbidity as well as mortality.