Role of probiotics VSL#3 in prevention of suspected sepsis in low birthweight infants in India: a randomised controlled trial

Study answer

What this study found

VSL#3 did not significantly reduce the primary fieldworker-diagnosed suspected sepsis outcome overall, but results were directionally favorable and a lighter-birthweight subgroup showed a clear benefit. Across all infants, suspected sepsis occurred in 84/668 (12.6%) with probiotic versus 107/672 (15.9%) with placebo, RR 0.79 (95% CI 0.56 to 1.03; p=0.080); incidence was 2.61 vs 3.40 per 1000 days, RR 0.77 (95% CI 0.59 to 0.99; p=0.0493). In infants weighing 1.5-1.99 kg, suspected sepsis was 4/74 (5.4%) versus 14/75 (18.7%), RR 0.29 (95% CI 0.10 to 0.84; p=0.014), with a lower incidence rate…

Study & population

Randomized, double-blind, placebo-controlled trial in low birthweight newborns in India, conducted at Safdarjung Hospital in New Delhi and the Mahatma Gandhi Institute of Medical Sciences in Wardha, with adjacent community follow-up.

Intervention

Infants in the active arm received VSL#3, an oral multi-strain probiotic powder, at 10 billion cfu per day for 30 days.

Key limitation

The primary outcome was not statistically significant, and several favorable findings came from subgroup or post hoc analyses, increasing the risk of chance findings.

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Original abstract