Authors: Katerina Kotzampassi, MD, Evagellos J. Giamarellos-Bourboulis, Antonios Voudouris, Pantelis Kazamias, Efthimios Eleftheriadis.
Published: Socie´te´ Internationale de Chirurgie. World J Surg (2006) 30.
The study was conducted in vivo, involving human participants.
Design: This study was a double-blind, placebo-controlled trial.
Treatment: Patients were randomly assigned to receive Synbiotic 2000 or placebo treatment according to a blinded list. It was given in doses once a day for a 15-day study period.
Where and when: ICUs of the Thessaloniki University’s tertiary-care AHEPA Hospitals and the affiliated 424th Military Hospital.
Sample size: 65 patients.
Sample criteria: All severe multiple trauma victims admitted over a 12- month period to any 1 of the 5 participating surgical ICUs of the Thessaloniki University’s tertiary-care AHEPA Hospitals and the affiliated 424th Military Hospital were eligible for the study. Patients were enrolled if they had two or more organ-system traumas, if it was predicted that they would have a long ICU stay and would need to be mechanically ventilated or under ventilatory support, if they were older than 18 years of age and with a life expectancy of more than 15 days after randomization. Pregnancy or lactation, immunosuppression, obesity (BMI > 40), or any contraindication to enteral administration of medication were additional causes for exclusion of patients from the study.
Analysed material: Infections, septic complications, mortality, days under ventilatory support, and days of stay in ICU were recorded.
The study evaluates the use of Synbiotic 2000 in managing patients with severe injuries. To determine whether Synbiotic 2000 can reduce complications like infections and improve recovery in trauma patients.
Results
Synbiotic-treated patients exhibited a significantly reduced rate of infections, SIRS, severe sepsis, and mortality. The overall infection rate was 63% in the synbiotic group in comparison with 90% in the placebo-treated group. The rate of SIRS and sepsis complications from 77% to 49%. The mortality rate was 30% in the placebo-treated group and14.3% in the synbiotic group. (1851).
Days of stay in the ICU and days under mechanical ventilation were significantly reduced in relation to placebo (a median of 15 days for the synbiotic group and a median of 26 for placebo).
Mean levels of PCT – had a highly statistically significant difference between groups, with the synbiotic group having the lowest. Similar was the expression profile of CRP in both groups. Concerning MDA, a very high mean value was found on day 4 in the placebo-treated group in relation to the synbiotic group, in which it was also elevated. The next measurements, on days 7 and 15, respectively, revealed a sharper reduction in the synbiotic group than in the placebo. Mean values in the synbiotic group were significantly reduced at any time point in relation to the placebo-treated group (s 1851).
Indicative results
The administration of this synbiotic formula in critically ill, mechanically ventilated, multiple trauma patients seems to exert beneficial effects in respect to infection and sepsis rates and to improve the patients response, thus reducing the duration of ventilatory support and intensive care treatment. (s. 1848).
The study found that the treatment can decrease the overall infection rate and the rate of SIRS and sepsis complications.
ICU research in this area was by this time in its early stages. The only pilot data available involved a comparison between treatment with live lactobacilli plus oat fiber and heat-treated lactobacilli with oat fiber as a control in critically ill patients with respect to multiorgan dysfunction. This is too small a study to allow statistical significance, the same unit is undertaking a large-scale trial (s. 1853).
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