Authors: Evangelos J. Giamarellos-Bourboulis, MD, PhD, Stig Bengmark, MD, PhD, Kyriaki Kanellakopoulou, MD, PhD, and Katerina Kotzampassi, MD, PhD.
Published: The Journal of TRAUMA Injury, Infection, and Critical Care. Volume 67, Number 4, October 2009.
The study was conducted in vivo, involving human participants.
Design: A doubleblind, placebo-controlled, multicenter, randomized clinical trial.
Treatment: A 15-day administration of either placebo or the synbiotic formula. On admission to the ICU, they were randomly assigned to receive either placebo or the formula Synbiotic 2000.
Where and when: The study was done in the five surgical ICUs of the Thessaloniki University’s tertiary-care AHEPA Hospitals and the affiliated 424th Military Hospital.
Sample size: 72 patients.
Sample criteria: All participants were bearing severe multiple organ injuries necessitating emergency tracheal intubation and ventilation support and subsequent hospitalization in the ICU. Patients with any previous hospitalization over the last 60 days were excluded from the study.
Analysed material: The association of bloodstream infections, ventilator-associated pneumonia (VAP), serum levels of C-reactive protein (CRP), and endotoxins (LPS) were studied.
Results
Sepsis in the field of bacteremia occurred in 13 patients treated with placebo compared with 5 patients treated with Synbiotic 2000.
Treatment with synbiotics was accompanied by reduction of white blood cell counts and LPS and CRP levels in either patients who did or did not develop sepsis. (s.815).
CRP values were lower among Synbiotic 2000 treated patients compared with placebo-treated patients on days 7 and 15. (s. 818).
25% of placebo treated and 5.6% of Synbiotic 2000 treated patients, respectively, developed primary bacteremia. The time to progression to primary bacteremia was longer among patients treated with Synbiotic 2000 compared with placebo. (s. 818).
When considering patients who developed primary bacteremia, WBCs were significantly lower among Synbiotic 2000 treated compared with placebo-treated patients on day 15. In the same patients, CRP levels were significantly lower among Synbiotic 2000 treated compared with placebo-treated patients on day 7 and on day 15. (s. 818).
Ten patients treated with placebo died (27.8%) compared with five patients treated with Synbiotic 2000 (13.9%,). All deaths were caused by multiple organ dysfunction syndrome. (s. 818).
Indicative results
Synbiotics contained in the studied formula significantly decreased the risk for sepsis by bloodstream infections. The mechanisms of action might involve direct immunomodulatory effect, prevention of bacterial translocation, or a combination of both (s.815).
Analysis revealed a considerable benefit of Synbiotic 2000 administration on the advent of bloodstream infections. The risk of sepsis due to bacteremia was significantly decreased along with the occurrence of primary bacteremia. The time to primary bacteremia was considerably prolonged, an effect which could have been even greater if the time of administration of Synbiotic 2000 had been prolonged. (s. 818).
The presented findings implicate prevention of bacterial translocation and a direct immunomodulatory effect as the most probable mechanisms of action of this synbiotic formula (s.820).
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