title: Lactobacillus Reuteri for the prevention of necrotising enterocolitis in very low birthweight infants: a randomised controlled trial.
abstract: OBJECTIVE
  To evaluate the effect of oral Lactobacillus reuteri (L reuteri) first on the incidence and severity of Necrotising enterocolitis (NEC) and second on sepsis.
  
  
  METHODS
  Prospective randomised controlled study.
  
  
  METHODS
  Tertiary neonatal intensive care unit.
  
  
  METHODS
  Preterm infants with a gestational age of ≤32 weeks and a birth weight of ≤1500 g were included (n=400). Infants in the first group were given 100 million CFU/day (5 drops) of lyophilised L reuteri (DSM 17938) mixed in breast milk or formula, starting from first feeding until discharge. Participants in the control group were given a placebo.
  
  
  METHODS
  To determine and compare the frequency of NEC and/or death after 7 days, frequency of proven sepsis, rates of feeding intolerance and duration of hospital stay.
  
  
  RESULTS
  There was no statistically significant difference between groups in terms of frequency of NEC stage ≥2 (4% vs 5%; p=0.63) or overall NEC or mortality rates (10% vs 13.5%; p=0.27). Frequency of proven sepsis was significantly lower in the probiotic group compared to the control group (6.5% vs 12.5%; p=0.041). A significant difference was also observed with regard to rates of feeding intolerance (28% vs 39.5%; p=0.015) and duration of hospital stay (38 (10-131) vs 46 (10-180) days; p=0.022).
  
  
  CONCLUSIONS
  Our results show that oral L reuteri does not seem to affect the overall rates of NEC and/or death in preterm infants followed up in the neonatal intensive care unit, and significant reductions were observed in the frequency of proven sepsis, rates of feeding intolerance and duration of hospital stay.
  
  
  BACKGROUND
  NCT01531179.
authors.affiliation: Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, , Ankara, Turkey.
authors.forename: Mehmet Yekta
authors.initials: MY
authors.lastname: Oncel
authors.forename: Fatma Nur
authors.initials: FN
authors.lastname: Sari
authors.forename: Sema
authors.initials: S
authors.lastname: Arayici
authors.forename: Nilufer
authors.initials: N
authors.lastname: Guzoglu
authors.forename: Omer
authors.initials: O
authors.lastname: Erdeve
authors.forename: Nurdan
authors.initials: N
authors.lastname: Uras
authors.forename: Serife Suna
authors.initials: SS
authors.lastname: Oguz
authors.forename: Ugur
authors.initials: U
authors.lastname: Dilmen
mesh_terms: D020345:Enterocolitis, Necrotizing / Q000401:mortality / Q000517:prevention & control*; D005260:Female; D006801:Humans; D015994:Incidence; D007231:Infant, Newborn; D007235:Infant, Premature, Diseases / Q000453:epidemiology / Q000517:prevention & control*; D019102:Infant, Very Low Birth Weight / Q000502:physiology*; D007363:Intensive Care Units, Neonatal; D052200:Limosilactobacillus reuteri; D007902:Length of Stay; D008297:Male; D019936:Probiotics / Q000627:therapeutic use*; D011446:Prospective Studies; D018805:Sepsis / Q000453:epidemiology / Q000517:prevention & control*; D012720:Severity of Illness Index
keywords: Feeding intolerance; lactobacillus reuteri; necrotizing enterocolitis; preterm infant