Probiotics in the critically ill patient: a double blind, randomized, placebo-controlled trial.
OBJECTIVE
Probiotics have been shown to be able to restore a non-pathogenic digestive flora, to prevent digestive colonization by pathogenic bacteria, and to modulate immunity. The aim of this study was to assess the effects of prophylactic probiotic administration in patients ventilated for up to 2 days.


METHODS
This study was performed as a double-blind, concealed randomized, placebo-controlled trial in a French medical intensive care unit (ICU). Adult patients mechanically ventilated for a period of more than 48 h received enterally administered probiotics (Ergyphilus, 2 x 10(10) lactic acid bacteria, mostly Lactobacillus rhamnosus GG, once a day) or placebo until successful weaning.


RESULTS
A total of 167 patients were included. The two groups were comparable at baseline. The 28-day mortality rates were not different in the probiotic (25.3%) and placebo groups (23.7%). Mortality rates in ICU and at 90 days were also unaffected by the treatment. The incidence of ICU-acquired infections did not differ significantly except for that of catheter-related bloodstream infections that was lowered by probiotics. On a prespecified subgroup analysis, we found a reduction of the 28-day mortality among severe sepsis patients (total n = 101) treated with probiotics (n = 52) with an odds ratio (OR) for death at 0.38 (95% CI 0.16-0.93, p = 0.035). By contrast, probiotics were associated with a higher mortality rate in non-severe sepsis patients (OR 3.09, 95% CI 0.87-11.01, p = 0.08).


CONCLUSIONS
Although numerous uncertainties remain (type and the number of strains to use, delay and length of administration), and despite an acceptable safety profile, the daily prophylactic administration of probiotics cannot be encouraged in the critically ill patient.
Barraud
Damien
D
Service de Réanimation Médicale, Hôpital Central, CHU Nancy, 29 avenue du Maréchal de Lattre de Tassigny, 54035, Nancy Cedex, France.
Blard
Claire
C
Hein
François
F
Marçon
Olivier
O
Cravoisy
Aurélie
A
Nace
Lionel
L
Alla
François
F
Bollaert
Pierre-Edouard
PE
Gibot
Sébastien
S
D000328:Adult; D000368:Aged; D003422:Critical Care / Q000379:methods*; D016638:Critical Illness; D003428:Cross Infection / Q000517:prevention & control; D004311:Double-Blind Method; D005260:Female; D005602:France; D006801:Humans; D007362:Intensive Care Units / Q000458:organization & administration; D052201:Lacticaseibacillus rhamnosus; D008297:Male; D008875:Middle Aged; D053717:Pneumonia, Ventilator-Associated / Q000188:drug therapy / Q000517:prevention & control*; D019936:Probiotics / Q000008:administration & dosage*; D012720:Severity of Illness Index; D016896:Treatment Outcome