Effects of probiotic supplementation on infectious and gastrointestinal complications of critically ill patients: Randomized, blinded, placebo-controlled clinical trial.

BACKGROUND

Critically ill patients frequently experience alterations in gut microbiota, known as dysbiosis, which has been associated with unfavorable clinical outcomes. The use of probiotics is one approach to modulating gut microbiota.

OBJECTIVE

This study aimed to evaluate the effects of probiotic supplementation combined with enteral nutrition (EN) in critically ill patients on infectious, gastrointestinal complications, and clinical outcomes.

METHODS

This is a randomized, blinded, placebo-controlled clinical trial conducted with 70 individuals aged ≥18 years, receiving enteral nutrition, and admitted to the emergency intensive care unit (ICU) of a tertiary hospital. The intervention consisted of Lactobacillus paracasei SD 5275, Lactobacillus rhamnosus SD 5675, Lactobacillus acidophilus SD 5221, and Bifidobacterium lactis SD 5674 (10 Colony Forming Units (CFU) of each bacterium/sachet, two sachets per day were used), administered via EN once daily for at least 5 days until ICU discharge, death, or initiation of an oral diet. The primary outcomes were the occurrence of infections and gastrointestinal symptoms. Secondary outcomes included the use of antibiotics, laxatives, prokinetics, duration of mechanical ventilation (MV), ICU stay, and mortality.

RESULTS

There was no significant difference in the occurrence of any type of infection or gastrointestinal symptoms between the groups (p ≥ 0.05). The use of antibiotics and laxatives was similar between the groups (p = 1.000 and 0.917, respectively). The average duration of prokinetic use was shorter in the intervention group (2.80 ± 1.52 vs. 6.08 ± 5.58 days, 95 % Confidence interval (CI) -1.39; -0.0594, p = 0.011). Although the number of days on mechanical ventilation, ICU stay, and mortality were lower in the patients who received probiotics, no significant differences were observed between the groups (p ≥ 0.05).

CONCLUSION

It is concluded that ICU patients supplemented with probiotics have a shorter duration of prokinetic use. However, supplementation does not directly impact gastrointestinal symptoms, infections, antibiotic use, laxative use, duration of mechanical ventilation, ICU stay, or mortality.

REGISTERED AT

Brazilian Clinical Trials Registry (ReBEC) under the number: ID RBR-2kqnj2t. SITE: https://ensaiosclinicos.gov.br/welcome.