TY - JOUR T1 - Role of probiotics VSL#3 in prevention of suspected sepsis in low birthweight infants in India: a randomised controlled trial JF - BMJ Open JO - BMJ Open DO - 10.1136/bmjopen-2014-006564 VL - 5 IS - 7 SP - e006564 AU - Anju Sinha AU - Subodh S Gupta AU - Harish Chellani AU - Chetna Maliye AU - Vidya Kumari AU - Sugandha Arya AU - BS Garg AU - Sunita Dixit Gaur AU - Rajni Gaind AU - Vijayshri Deotale AU - Manish Taywade AU - MS Prasad AU - Vasantha Thavraj AU - Ajit Mukherjee AU - Malabika Roy Y1 - 2015/07/01 UR - http://bmjopen.bmj.com/content/5/7/e006564.abstract N2 - 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). ER -