title: Oral probiotic and prevention of Pseudomonas aeruginosa infections: a randomized, double-blind, placebo-controlled pilot study in intensive care unit patients.
abstract: BACKGROUND
  Preventing carriage of potentially pathogenic micro-organisms from the aerodigestive tract is an infection control strategy used to reduce the occurrence of ventilator-associated pneumonia in intensive care units. However, antibiotic use in selective decontamination protocols is controversial. The purpose of this study was to investigate the effect of oral administration of a probiotic, namely Lactobacillus, on gastric and respiratory tract colonization/infection with Pseudomonas aeruginosa strains. Our hypothesis was that an indigenous flora should exhibit a protective effect against secondary colonization.
  
  
  METHODS
  We conducted a prospective, randomized, double-blind, placebo-controlled pilot study between March 2003 and October 2004 in a 17-bed intensive care unit of a teaching hospital in Clermont-Ferrand, France. Consecutive patients with a unit stay of longer than 48 hours were included, 106 in the placebo group and 102 in the probiotic group. Through a nasogastric feeding tube, patients received either 109 colony-forming units unity forming colony of Lactobacillus casei rhamnosus or placebo twice daily, from the third day after admission to discharge. Digestive tract carriage of P. aeruginosa was monitored by cultures of gastric aspirates at admission, once a week thereafter and on discharge. In addition, bacteriological analyses of respiratory tract specimens were conducted to determine patient infectious status.
  
  
  RESULTS
  The occurrence of P. aeruginosa respiratory colonization and/or infection was significantly delayed in the probiotic group, with a difference in median delay to acquisition of 11 days versus 50 days (P = 0.01), and a nonacquisition expectancy mean of 69 days versus 77 days (P = 0.01). The occurrence of ventilator-associated pneumonia due to P. aeruginosa in the patients receiving the probiotic was less frequent, although not significantly reduced, in patients in the probiotic group (2.9%) compared with those in the placebo group (7.5%). After multivariate Cox proportional hazards modelling, the absence of probiotic treatment increased the risk for P. aeruginosa colonization in respiratory tract (adjusted hazard ratio = 3.2, 95% confidence interval - 1.1 to 9.1).
  
  
  CONCLUSIONS
  In this pilot study, oral administration of a probiotic delayed respiratory tract colonization/infection by P. aeruginosa.
  
  
  BACKGROUND
  The trial registration number for this study is NCT00604110.
authors.affiliation: Université de Clermont 1 UFR Pharmacie Laboratoire de Bactériologie, 28 place Henri Dunant 63000 Clermont-Ferrand France. Christiane.forestier@u-clermont1.fr
authors.forename: Christiane
authors.initials: C
authors.lastname: Forestier
authors.forename: Dominique
authors.initials: D
authors.lastname: Guelon
authors.forename: Valérie
authors.initials: V
authors.lastname: Cluytens
authors.forename: Thierry
authors.initials: T
authors.lastname: Gillart
authors.forename: Jacques
authors.initials: J
authors.lastname: Sirot
authors.forename: Christophe
authors.initials: C
authors.lastname: De Champs
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D007780:Lacticaseibacillus casei; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D019936:Probiotics / Q000627:therapeutic use*; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011552:Pseudomonas Infections / Q000517:prevention & control*; D012137:Respiratory System / Q000382:microbiology; D012141:Respiratory Tract Infections / Q000517:prevention & control*; D013270:Stomach / Q000382:microbiology