Limits...
Oral probiotic and prevention of Pseudomonas aeruginosa infections: a randomized, double-blind, placebo-controlled pilot study in intensive care unit patients.

Forestier C, Guelon D, Cluytens V, Gillart T, Sirot J, De Champs C - Crit Care (2008)

Bottom Line: Our hypothesis was that an indigenous flora should exhibit a protective effect against secondary colonization.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).

View Article: PubMed Central - HTML - PubMed

Affiliation: Université de Clermont 1 UFR Pharmacie Laboratoire de Bactériologie, 28 place Henri Dunant 63000 Clermont-Ferrand France. Christiane.forestier@u-clermont1.fr

ABSTRACT

Introduction: 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).

Conclusion: In this pilot study, oral administration of a probiotic delayed respiratory tract colonization/infection by P. aeruginosa.

Trial registration: The trial registration number for this study is NCT00604110.

Show MeSH

Related in: MedlinePlus

Patient flowchart.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC2481460&req=5

Figure 1: Patient flowchart.

Mentions: A total of 807 patients were admitted in the unit during the period of the survey; 571 were not randomized: 242 because they did not meet inclusion criteria (219 stayed < 48 hours), 299 because patient consent was not obtained, and 30 because the patients were included in another protocol. After randomization, 28 were excluded because of occurrence of exclusion criteria or because the patients no longer wished to participate (see patient flowchart in Figure 1), and therefore 208 patients were included. Of the excluded patients, 380 had a length of stay of longer than 48 hours. There was no difference in underlying medical disease between the 208 included patients and the 599 excluded ones. The age of the 208 included patients did not differ from that of the 380 excluded ones who stayed for longer than 48 hours (mean [± standard deviation] age: 57 ± 16 years versus 54 ± 19 years), but their length of stay was longer (mean 21 ± 19 days versus 13 ± 18 days; P < 0.000001) and their severity of illness or injury was greater (SAPS II score: 44 ± 17 versus 37 ± 18; P < 0.0001). However, the reasons for their admission were similar, except for digestive tract pathologies because of digestive haemorrhages (which were exclusion criteria) and cancers (7/208 versus 35/380; P = 0.01).


Oral probiotic and prevention of Pseudomonas aeruginosa infections: a randomized, double-blind, placebo-controlled pilot study in intensive care unit patients.

Forestier C, Guelon D, Cluytens V, Gillart T, Sirot J, De Champs C - Crit Care (2008)

Patient flowchart.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2481460&req=5

Figure 1: Patient flowchart.
Mentions: A total of 807 patients were admitted in the unit during the period of the survey; 571 were not randomized: 242 because they did not meet inclusion criteria (219 stayed < 48 hours), 299 because patient consent was not obtained, and 30 because the patients were included in another protocol. After randomization, 28 were excluded because of occurrence of exclusion criteria or because the patients no longer wished to participate (see patient flowchart in Figure 1), and therefore 208 patients were included. Of the excluded patients, 380 had a length of stay of longer than 48 hours. There was no difference in underlying medical disease between the 208 included patients and the 599 excluded ones. The age of the 208 included patients did not differ from that of the 380 excluded ones who stayed for longer than 48 hours (mean [± standard deviation] age: 57 ± 16 years versus 54 ± 19 years), but their length of stay was longer (mean 21 ± 19 days versus 13 ± 18 days; P < 0.000001) and their severity of illness or injury was greater (SAPS II score: 44 ± 17 versus 37 ± 18; P < 0.0001). However, the reasons for their admission were similar, except for digestive tract pathologies because of digestive haemorrhages (which were exclusion criteria) and cancers (7/208 versus 35/380; P = 0.01).

Bottom Line: Our hypothesis was that an indigenous flora should exhibit a protective effect against secondary colonization.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).

View Article: PubMed Central - HTML - PubMed

Affiliation: Université de Clermont 1 UFR Pharmacie Laboratoire de Bactériologie, 28 place Henri Dunant 63000 Clermont-Ferrand France. Christiane.forestier@u-clermont1.fr

ABSTRACT

Introduction: 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).

Conclusion: In this pilot study, oral administration of a probiotic delayed respiratory tract colonization/infection by P. aeruginosa.

Trial registration: The trial registration number for this study is NCT00604110.

Show MeSH
Related in: MedlinePlus