Effect of enteral probiotics on prognostic scores and C-reactive protein levels in critically ill multiple trauma patients: A randomized, double-blind, placebo-controlled clinical trial

BACKGROUND AND AIMS:To evaluate the effect of a one-week LactoCare® oral probiotic supplementation on prognostic scores (APACHE II: acute physiology and chronic health evaluation II; SAPS II: simplified acute physiology score II; SOFA: sequential organ failure assessment), C-reactive protein (CRP) levels, and other outcomes in multiple trauma (MT) patients requiring intensive care compared to placebo. MATERIAL AND METHODS:A randomized, double-blind, placebo-controlled clinical trial. The population included MT patients admitted to ICUs of two referral centers in Isfahan, Iran, from December 2021 to November 2022 (registered under IRCT. ir identifier no. IRCT20211006052684N1). LactoCare® and placebo were administered twice daily for one week. Prognostic scores and CRP levels were calculated/measured before and after the dedicated intervention. RESULTS:There was not a significant difference in APACHE II (p-value = 0.62), SAPS II (p-value = 0.70), SOFA (p-value = 0.71) scores, CRP levels (p-value = 0.25), median hospital days [LactoCare® vs. placebo] (28.00 vs. 22.50, p-value = 0.06), median ICU days (21.00 vs. 18.00, p-value = 0.16), and median days under mechanical ventilation (14.00 vs. 14.50, p-value = 0.74) between the LactoCare® and placebo groups. Also, 28-day mortality and time to discharge did not significantly differ between the two groups. CONCLUSION:Evidence from this trial does not support the use of oral probiotic supplementation for MT patients who are admitted to the ICU.