Single-Strain Versus Multistrain Probiotics in the Prevention of Late-Onset Sepsis in Preterm Neonates

Nandkishor Shrikishanji Kabra, Jagdish Kathwate, Haribalakrishna Balasubramanian, Swarup Kumar Dash, Bhupendra Suryanarayan Avasthi

Abstract

Aim: To evaluate the efficacy of a single-strain probiotic (SSP; ie, Saccharomyces boulardii) versus multistrain probiotics (MSPs; ie, Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, and S boulardii) in the prevention of late-onset sepsis (LOS) in preterm neonates.

Materials and Methods: This was a randomized, double-blind, comparative, controlled study, conducted at a level 3 NICU. A total of 343 preterm neonates, born at a gestational age of ≤ 34 weeks or having birth weight ≤ 1,500 g were enrolled. The neonates were stratified into 3 groups: (i) born at < 28 weeks, (ii) ≥ 28 to < 31 weeks, and (iii) ≥ 31 to ≤ 34 weeks or having birth weight ≤ 1,500 g. The interventions included an SSP and an MSP, both available as sachets, that were dissolved in 4 mL of distilled water and administered to the respective groups until the neonates were discharged or reached 37 weeks of gestation, whichever occurred earlier. The primary outcome measure was clinical LOS, while the secondary outcomes included culture-positive LOS, incidence of necrotizing enterocolitis of stage 2 or 3, all-cause mortality before discharge, and effects on growth.

Results: The primary outcome of clinical LOS occurred in 36 of 169 neonates (21%) in the SSP group and 32 of 174 neonates (18%) in the MSP group. This difference was statistically not significant (P = .58). The incidence of culture-positive LOS was in 21 of 169 (12%) and in 15 of 174 (9%) in the SSP and the MSP groups, respectively. This difference was statistically not significant (P = .29).

Conclusion: The results demonstrate that MSPs are not better than SSPs in the prevention of LOS. None of the neonates with LOS had Lactobacillus, Bifidobacterium, or Saccharomyces bacteremia, indicating that the usage of probiotics is safe in preterm neonates.