Clinical safety of Lactobacillus casei shirota as a probiotic in critically ill children

J Pediatr Gastroenterol Nutr. 2006 Feb;42(2):171-3. doi: 10.1097/


Objective: Diarrhea is frequently observed among critically ill children (CIC) admitted for intensive care. There is increasing evidence that probiotics decrease the incidence of acute infectious and nosocomial and antibiotic induced diarrhea amongst children hospitalized in nonintensive care settings. Despite theoretic advantages for the use of probiotics in CIC, safety has remained a concern in this vulnerable group. The objective of this study was to establish clinical safety (invasive infection/colonization) of Lactobacillus casei shirota (LCS) used as a probiotic in CIC.

Methods: Prospective, descriptive pilot study on children admitted to a pediatric intensive care unit. Data regarding safety were collected on the initial recruits to a randomized controlled trial aimed to study the effects of LCS on stool frequency and consistency in CIC. Safety was assessed by bacteriologic surveillance for LCS in surface swabs and endotracheal aspirates (colonization) as well as blood, urine, and sterile body fluid cultures (invasive infection/bacteremia).

Results: Safety data were available on 28 patients. LCS was cultured from the feces of five of the six study subjects who opened bowels during their stay on the pediatric intensive care unit. There was no evidence of either colonization or bacteremia with LCS in bacteriologic cultures obtained from study subjects. The preparation was well tolerated with no apparent side effects.

Conclusions: Our pilot safety study suggests that the use of LCS as a probiotic in enterally fed CIC is safe.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Child
  • Child, Preschool
  • Colony Count, Microbial
  • Critical Illness / therapy*
  • Diarrhea / microbiology*
  • Diarrhea / therapy*
  • Double-Blind Method
  • Enteral Nutrition
  • Female
  • Humans
  • Infant
  • Intensive Care Units, Pediatric
  • Lacticaseibacillus casei / growth & development*
  • Lacticaseibacillus casei / isolation & purification
  • Lacticaseibacillus casei / physiology
  • Male
  • Pilot Projects
  • Probiotics* / adverse effects
  • Probiotics* / therapeutic use
  • Prospective Studies
  • Safety