Role of probiotics VSL#3 in prevention of suspected sepsis in low birthweight infants in India: a randomised controlled trial
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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Open PDFOriginal abstract
Objectives To assess the effect of the probiotic VSL#3 in prevention of neonatal sepsis in low birthweight (LBW) infants. Design Randomised, double-blind, placebo-controlled trial. Setting Community setting in rural India. Participants LBW infants aged 3–7 days. Interventions Infants were randomised to receive probiotic (VSL#3, 10 billion colony-forming units (cfu)) or placebo for 30 days, and were followed up for 2 months. Main outcome measure Possible serious bacterial infection (PSBI) as per the Integrated Management of Neonatal Childhood Illnesses algorithm, as diagnosed by fieldworkers/physicians. Results 668 infants were randomised to VSL#3 and 672 to placebo. By intention-to-treat analysis, the risk of PSBI among infants in the overall population of LBW infants was not statistically significant (RR 0.79 (95% CI 0.56 to 1.03)). Probiotics reduced median days of hospitalisation (6 days vs 3 days in probiotics) (p=0.018) but not the risk of hospitalisation (RR 0.66 (95% CI 0.42 to 1.04). The onset of PSBI in 10% of infants occurred on the 40th day in the probiotics arm versus the 25th day in the control arm (p=0.063). Conclusions Daily supplementation of LBW infants with probiotics VSL#3 (10 billion cfu) for 30 days led to a non-significant 21% reduction in risk of neonatal sepsis. A larger study with sufficient power and a more specific primary end point is warranted to confirm the preventive effect of VSL#3 on neonatal sepsis in LBW infants. Trial registration number The study is registered at the Clinical Trial Registry of India (CTRI/2008/091/000049).