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Randomized Controlled Trial
. 2015 Jul 10;5(7):e006564.
doi: 10.1136/bmjopen-2014-006564.

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

Anju Sinha  1 , Subodh S Gupta  2 , Harish Chellani  3 , Chetna Maliye  2 , Vidya Kumari  3 , Sugandha Arya  3 , B S Garg  2 , Sunita Dixit Gaur  4 , Rajni Gaind  3 , Vijayshri Deotale  2 , Manish Taywade  2 , M S Prasad  3 , Vasantha Thavraj  1 , Ajit Mukherjee  1 , Malabika Roy  1
Affiliations
Randomized Controlled Trial

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

Anju Sinha et al. BMJ Open. .

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).

Keywords: NEONATOLOGY.

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Figures

Figure 1
Figure 1
Participant flow through the trial.
Figure 2
Figure 2
Kaplan-Meier curves for difference between event rates in the probiotic and placebo groups. PSBI, possible serious bacterial infection.
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