title: The propre-save study: effects of probiotics and prebiotics alone or combined on necrotizing enterocolitis in very low birth weight infants.
abstract: OBJECTIVE
  To test the efficacy of probiotic and prebiotic, alone or combined (synbiotic), on the prevention of necrotizing enterocolitis (NEC) in very low birth weight (VLBW) infants.
  
  
  METHODS
  A prospective, randomized, controlled trial was conducted at 5 neonatal intensive care units in Turkey. VLBW infants (n = 400) were assigned to a control group and 3 study groups that were given probiotic (Bifidobacterium lactis), prebiotic (inulin), or synbiotic (Bifidobacterium lactis plus inulin) added to breastmilk or formula for a maximum of 8 weeks before discharge or death. The primary outcome was NEC (Bell stage ≥2).
  
  
  RESULTS
  The rate of NEC was lower in probiotic (2.0%) and synbiotic (4.0%) groups compared with prebiotic (12.0%) and placebo (18.0%) groups (P < .001). The times to reach full enteral feeding were faster (P < .001), the rates of clinical nosocomial sepsis were lower (P = .004), stays in the neonatal intensive care unit were shorter, (P = .002), and mortality rates were lower (P = .003) for infants receiving probiotics, prebiotics, or synbiotic than controls. The use of antenatal steroid (OR 0.5, 95% CI 0.3-0.9) and postnatal probiotic (alone or in synbiotic) (OR 0.5, 95% CI 0.2-0.8) decreased the risk of NEC, and maternal antibiotic exposure increased this risk (OR 1.9, 95% CI 1.1-3.6).
  
  
  CONCLUSIONS
  In VLBW infants, probiotic (Bifidobacterium lactis) and synbiotic (Bifidobacterium lactis plus inulin) but not prebiotic (inulin) alone decrease NEC.
authors.affiliation: Department of Neonatology, Dr Sami Ulus Maternity and Children Research and Training Hospital, Ankara, Turkey. Electronic address: dilekdilli2@yahoo.com.
authors.forename: Dilek
authors.initials: D
authors.lastname: Dilli
authors.affiliation: Department of Neonatology, Dr Sami Ulus Maternity and Children Research and Training Hospital, Ankara, Turkey.
authors.forename: Banu
authors.initials: B
authors.lastname: Aydin
authors.affiliation: Department of Neonatology, Dr Sami Ulus Maternity and Children Research and Training Hospital, Ankara, Turkey.
authors.forename: Nurdan Dinlen
authors.initials: ND
authors.lastname: Fettah
authors.affiliation: Department of Neonatology, Dr Sami Ulus Maternity and Children Research and Training Hospital, Ankara, Turkey.
authors.forename: Elif
authors.initials: E
authors.lastname: Özyazıcı
authors.affiliation: Department of Neonatology, Dr Sami Ulus Maternity and Children Research and Training Hospital, Ankara, Turkey.
authors.forename: Serdar
authors.initials: S
authors.lastname: Beken
authors.affiliation: Department of Neonatology, Dr Sami Ulus Maternity and Children Research and Training Hospital, Ankara, Turkey.
authors.forename: Ayşegül
authors.initials: A
authors.lastname: Zenciroğlu
authors.affiliation: Department of Neonatology, Dr Sami Ulus Maternity and Children Research and Training Hospital, Ankara, Turkey.
authors.forename: Nurullah
authors.initials: N
authors.lastname: Okumuş
authors.affiliation: Department of Neonatology, Diyarbakir Maternity and Children Hospital, Diyarbakır, Turkey.
authors.forename: Banu Mutlu
authors.initials: BM
authors.lastname: Özyurt
authors.affiliation: Department of Neonatology, Diyarbakir Maternity and Children Hospital, Diyarbakır, Turkey.
authors.forename: Mehmet Şah
authors.initials: MŞ
authors.lastname: İpek
authors.affiliation: Department of Neonatology, Bursa Şevket Yılmaz Training and Research Hospital, Bursa, Turkey.
authors.forename: Arzu
authors.initials: A
authors.lastname: Akdağ
authors.affiliation: Department of Neonatology, Okmeydanı Education and Research Hospital, İstanbul, Turkey.
authors.forename: Özden
authors.initials: Ö
authors.lastname: Turan
authors.affiliation: Department of Neonatology, Ümraniye Training and Research Hospital, İstanbul, Turkey.
authors.forename: Şenol
authors.initials: Ş
authors.lastname: Bozdağ
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D020345:Enterocolitis, Necrotizing / Q000453:epidemiology / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007231:Infant, Newborn; D007234:Infant, Premature; D019102:Infant, Very Low Birth Weight; D008297:Male; D056692:Prebiotics; D019936:Probiotics / Q000627:therapeutic use*; D011446:Prospective Studies; D013997:Time Factors; D014421:Turkey / Q000453:epidemiology
chemical_list: D056692:Prebiotics