title: Bacillus clausii for Prevention of Late-onset Sepsis in Preterm Infants: A Randomized Controlled Trial.
abstract: BACKGROUND
  Preterm infants are managed with antibiotics for sepsis, including suspected or probable sepsis. This leads to a delayed and abnormal colonization of the gut with potentially pathogenic organisms and a microbiome, which lacks biodiversity and increases the risk for late-onset sepsis (LOS). Probiotics have been proven to reduce the risk for necrotizing enterocolitis, but evidence for prevention of LOS is inconclusive. Probiotic effect depends also on the strain used, dose and indication for use. This study evaluated Bacillus clausii probiotic administered prophylactically to preterm neonates for prevention of LOS.
  
  
  OBJECTIVE
  To study B.clausii given prophylactically to preterm neonates for prevention of LOS.
  
  
  METHODS
  Double-blinded, placebo-controlled, randomized trial.
  
  
  METHODS
  Tertiary care neonatal unit in India.
  
  
  METHODS
  Consecutive preterm neonates <34 weeks, admitted from 1 March 2012 to 28 February 2014 were stratified as extreme preterm and very preterm.
  
  
  METHODS
  Randomized to receive either probiotic or placebo for 6 weeks, discharge from hospital, death or occurrence of sepsis, whichever was earlier.
  
  
  METHODS
  Incidence of definite and probable LOS in probiotic group compared with placebo.
  
  
  RESULTS
  Of 326 eligible preterm infants, 244 were enrolled and 82 were excluded. Of these, 120 were stratified as extreme preterm and randomized to receive placebo (n = 59) and probiotic (n = 61). Of 124 babies stratified as very preterm, an equal number was randomized to receive placebo (n = 62) and probiotic (n = 62). There was no significant difference in the incidence of LOS between the two arms in the extreme preterm group [29% vs. 23%; relative risk (RR) 1.27; 95% confidence interval (CI) 0.88-1.66; p = 0.36] and the very preterm group (13% vs. 10%; RR 1.33; 95% CI 0.96-1.70; p = 0.32). Full feeds were achieved significantly faster in the probiotic group in both the extreme preterm (RR 0.82; 95% CI 0.74-0.88) and the very preterm (RR 0.67; 95% 0.32-0.77).
  
  
  CONCLUSIONS
  Prophylactic administration of B.clausii to preterm neonates did not result in a significant difference in the incidence of LOS as compared with placebo.
authors.affiliation: Department of Pediatrics, Army Hospital (Referral & Research) New Delhi, India docvvt_13@hotmail.com.
authors.forename: Vishal Vishnu
authors.initials: VV
authors.lastname: Tewari
authors.affiliation: Department of Pediatrics, Army Hospital (Referral & Research) New Delhi, India.
authors.forename: Sachin Kumar
authors.initials: SK
authors.lastname: Dubey
authors.affiliation: INHS Sanjeevani Kochi, India.
authors.forename: Girish
authors.initials: G
authors.lastname: Gupta
mesh_terms: D001407:Bacillus; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007194:India; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000401:mortality / Q000517:prevention & control*; D016015:Logistic Models; D008297:Male; D065129:Pre-Exposure Prophylaxis; D019936:Probiotics / Q000008:administration & dosage* / Q000627:therapeutic use*; D011446:Prospective Studies; D018805:Sepsis / Q000401:mortality / Q000517:prevention & control*; D016896:Treatment Outcome
keywords: Bacillus clausii; late-onset sepsis; probiotic