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Role of probiotics VSL#3 in prevention of suspected sepsis in low birthweight infants in India: a randomised controlled trial
  1. Anju Sinha1,
  2. Subodh S Gupta2,
  3. Harish Chellani3,
  4. Chetna Maliye2,
  5. Vidya Kumari3,
  6. Sugandha Arya3,
  7. BS Garg2,
  8. Sunita Dixit Gaur4,
  9. Rajni Gaind3,
  10. Vijayshri Deotale2,
  11. Manish Taywade2,
  12. MS Prasad3,
  13. Vasantha Thavraj1,
  14. Ajit Mukherjee1,
  15. Malabika Roy1
  1. 1Department of Reproductive and Child Health, Indian Council of Medical Research, New Delhi, Delhi, India
  2. 2Mahatma Gandhi Institute of Medical Sciences, Sewagram, Maharashtra, India
  3. 3Safdarjung Hospital, New Delhi, Delhi, India
  4. 4District Hospital Wardha, Wardha, Maharashtra, India
  1. Correspondence to Dr Anju Sinha; apradhandr{at}


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).


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