OBJECTIVE: To investigate the effect of enteral Synbiotic 2000 FORTE (a mixture of lactic acid bacteria and fibre) on the incidence of ventilator associated pneumonia (VAP) in critically ill patients. DESIGN: Prospective, randomised, double blind, placebo controlled trial. SETTING:Tertiary referral centre, general Adult Intensive Care Unit (ICU). PATIENTS AND PARTICIPANTS: 259 enterally fed patients requiring mechanical ventilation for 48 h or more were enrolled. INTERVENTION: All patients were enterally fed as per a standard protocol and randomly assigned to receive either synbiotic 2000 FORTE (twice a day) or a cellulose-based placebo for a maximum of 28 days. MEASUREMENTS AND RESULTS: Treatment group (n = 130) was well matched with placebogroup (n = 129) for age (mean 49.5 and 50 years, respectively) and APACHE II score (median 17 for both). Oropharyngeal microbial flora and colonisation rates were unaffected by synbiotics. The overall incidence of VAP was lower than anticipated (11.2%) and no statistical difference was demonstrated between groups receiving synbiotic and placebo in the incidence of VAP (9 and 13%, P = 0.42), VAP rate per 1,000 ventilator days (13 and 14.6, P = 0.91) or hospital mortality (27 and 33%, P = 0.39), respectively. CONCLUSIONS: Enteral administration of Synbiotic 2000 FORTE has no statistically significant impact on the incidence of VAP in critically ill patients.
RCT Entities:
OBJECTIVE: To investigate the effect of enteral Synbiotic 2000 FORTE (a mixture of lactic acid bacteria and fibre) on the incidence of ventilator associated pneumonia (VAP) in critically illpatients. DESIGN: Prospective, randomised, double blind, placebo controlled trial. SETTING: Tertiary referral centre, general Adult Intensive Care Unit (ICU). PATIENTS AND PARTICIPANTS: 259 enterally fed patients requiring mechanical ventilation for 48 h or more were enrolled. INTERVENTION: All patients were enterally fed as per a standard protocol and randomly assigned to receive either synbiotic 2000 FORTE (twice a day) or a cellulose-based placebo for a maximum of 28 days. MEASUREMENTS AND RESULTS: Treatment group (n = 130) was well matched with placebo group (n = 129) for age (mean 49.5 and 50 years, respectively) and APACHE II score (median 17 for both). Oropharyngeal microbial flora and colonisation rates were unaffected by synbiotics. The overall incidence of VAP was lower than anticipated (11.2%) and no statistical difference was demonstrated between groups receiving synbiotic and placebo in the incidence of VAP (9 and 13%, P = 0.42), VAP rate per 1,000 ventilator days (13 and 14.6, P = 0.91) or hospital mortality (27 and 33%, P = 0.39), respectively. CONCLUSIONS: Enteral administration of Synbiotic 2000 FORTE has no statistically significant impact on the incidence of VAP in critically illpatients.
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