title: Tolerance, safety, and effect on the faecal microbiota of an enteral formula supplemented with pre- and probiotics in critically ill children.
abstract: OBJECTIVE
  The aim of this study was to demonstrate the tolerance and safety of an enteral formula containing prebiotics/probiotics, and its effect on the faecal microbiota in critically ill children.
  
  
  METHODS
  Ninety-four patients between 1 and 3 years old under mechanical ventilation requiring enteral feeding were randomised to receive either a test formula containing a synbiotic blend (composed of 2 probiotic strains [Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC 3001], fructooligosaccharides [FOS], inulin, and Acacia gum), or a control formula. Patients remained in the intensive care unit for 7 days and were examined at day 14. Tolerance was assessed by overall caloric intake and time to reach caloric goal. Safety was assessed by abdominal distention, vomiting, and stool frequency. Microbiota was analysed by culture- and molecular-based methods.
  
  
  RESULTS
  Overall caloric intake and time to reach caloric goal were similar between groups (noninferiority was shown). Abdominal distention, vomiting, and stool frequency were not affected by the supplementation with pre- and probiotics. Faecal bifidobacteria were higher in the test group at the end of the study. A similar trend was observed for total lactobacilli. L paracasei NCC 2461 and B longum NCC 3001 were detected in 80.4% and 17% of the test group patients, respectively. Enterobacteria levels remained unchanged during hospitalisation in the control group but diminished in the test group.
  
  
  CONCLUSIONS
  The enteral formula supplemented with synbiotics was well tolerated by children in intensive care units; it was safe and produced an increase in faecal bacterial groups of previously reported beneficial effects.
authors.affiliation: Department of Paediatrics, Maharat Nakhon Ratchasima Hospital, Nakhon Ratchasima, Thailand.
authors.forename: Nipat
authors.initials: N
authors.lastname: Simakachorn
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Bibiloni
authors.forename: Phisek
authors.initials: P
authors.lastname: Yimyaem
authors.forename: Yothi
authors.initials: Y
authors.lastname: Tongpenyai
authors.forename: Wandee
authors.initials: W
authors.lastname: Varavithaya
authors.forename: Dominik
authors.initials: D
authors.lastname: Grathwohl
authors.forename: Gloria
authors.initials: G
authors.lastname: Reuteler
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Maire
authors.forename: Stephanie
authors.initials: S
authors.lastname: Blum
authors.forename: Philippe
authors.initials: P
authors.lastname: Steenhout
authors.forename: Jalil
authors.initials: J
authors.lastname: Benyacoub
authors.forename: Eduardo J
authors.initials: EJ
authors.lastname: Schiffrin
mesh_terms: D015746:Abdominal Pain / Q000453:epidemiology; D001644:Bifidobacterium / Q000302:isolation & purification; D002675:Child, Preschool; D003967:Diarrhea / Q000453:epidemiology; D004311:Double-Blind Method; D002149:Energy Intake; D004750:Enteral Nutrition; D056569:Enterococcaceae / Q000302:isolation & purification; D005243:Feces / Q000382:microbiology*; D005260:Female; D005526:Food, Formulated / Q000009:adverse effects*; D006706:Homeostasis; D006801:Humans; D007223:Infant; D015278:Intensive Care Units, Pediatric; D007778:Lactobacillus / Q000302:isolation & purification; D008297:Male; D056692:Prebiotics / Q000009:adverse effects*; D019936:Probiotics / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D014839:Vomiting / Q000453:epidemiology
chemical_list: D056692:Prebiotics