Benefits of Synbiotic 2000 Forte in critically ill patients: a randomized controlled trial

Background and aim

Early probiotics administration was suggested to reduce the incidence of infections and thus the overall morbidity and mortality in surgical patients. The aim of this prospective randomized clinical trial was to assess the effects of a combination formula of probiotics and prebiotics (Synbiotic 2000 Forte; Medifarm, Sweden) versus prebiotics only (fiber) in critically ill, long-term mechanically ventilated trauma patients.

Materials and methods

Patients were randomized to either treatment for a 2-week treatment period. Synbiotic 2000 Forte consists of 10¹⁰ CFU of each of Pediococcus pentoseceus 5–33:3, Leuconostoc mesenteroides 32–77:1, L. paracasei ssp paracasei 19 and L. plantarum 2362, as well as 2.5 g inulin, oat bran, pectin and resistant starch. Blood samples were collected on days 0, 4, 7 and 15 for measurements of CRP, PCT, MDA, tumor necrosis factor alpha, IL-6. Days under ventilatory support, days of total stay in the ICU, gut motility, antibiotic-associated diarrheas, infections, and septic morbidity as well as overall mortality were also recorded.

Results

Patients were well matched regarding age and sex distribution, APACHE II and Glasgow scores. From day 7, all patients of the Synbiotic group exhibited a progressive reduction of all inflammatory indexes in relation to the prebiotics only group (P = 0.05). Similarly, they had a significantly shorter ICU stay and days on mechanical ventilation (P = 0.04), less episodes of antibiotic-associated diarrheas and less distension and cramps after enteral nutrition, in relation to the prebiotics group. The overall infection rate was 34% versus 90%, respectively, while three patients from the prebiotics group died after sepsis and MODS.

Conclusion

The administration of the Synbiotic 2000 Forte formula in critically ill ventilated trauma patients favorably altered the systemic inflammatory response and seemed to be associated with measurable clinical benefits.