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Effect of the probiotic VSL#3 on neonatal sepsis in infants with low birth weight

Posted:  Friday, August 26, 2016

Role of probiotic VSL#3 on neonatal sepsis in infants with low birth weight

Infants with low birth weight (LBW) are at high risk for neonatal sepsis. A randomised, placebo-controlled, double-blind trial published in the journal BMJ Open evaluated the effect of daily supplementation of probiotic VSL#3 in preventing neonatal sepsis in low birth weight (LBW) infants.

A total of 1,340 low birth weight infants aged 3–7 days were randomly assigned to receive a daily supplementation of probiotic VSL#3 (10 billion colony-forming units) or placebo for 30 days. They were followed up for 2 months for incidence of neonatal sepsis and other morbidities. The Integrated Management of Neonatal Childhood Illnesses algorithm was used to identify possible serious bacterial infection (PSBI).

According to the intention-to-treat analysis, a non-significant reduction (21%) in the overall risk of PSBI was seen among infants receiving probiotics. However, the effect was significant in the un-prespecified subgroup of infants with birth weights 1.5–1.99 kg and in female infants. The median number of hospitalisations was low among infants in the probiotic group compared to those in the placebo group (3 days vs. 6 days). The first incidence of PSBI in 10% of infants occurred on the 41st day in the probiotic group versus the 25th day in the control group. The first incidence of suspected sepsis in 5% of infants occurred on the 26th day in the control group versus the 53rd day in the probiotic group.

The study findings suggested that the risk of neonatal sepsis reduced non-significantly in LBW infants supplemented with probiotics VSL#3 for 30 days. A significant positive treatment effect was observed in the subgroup of infants weighing 1.5–2.0 kg. The mean number of hospitalisation days was significantly reduced as a result of probiotic intervention. Further trials with more specific primary end points are required to confirm the effect of VSL#3 on neonatal sepsis in LBW infants.

News source - Sinha A, Gupta SS, Chellani H et al. Role of probiotics VSL# 3 in prevention of suspected sepsis in low birthweight infants in India: a randomised controlled trial. BMJ open. 2015 Jul 1; 5(7):e006564.