Randomized, double-blind, placebo-controlled study of the efficacy of four probiotics to modify the risk for postoperative complications in colorectal surgery

Abstract

Introduction Heterogeneous published results led us to conduct a clinical trial to assess the efficacy of a new formulation of four probiotics (P) as prophylaxis for complications after colorectal surgery. Methods A double-blind, placebo-controlled randomized study was conducted enrolling patients undergoing colorectal cancer surgery. Placebo or a formulation of L. acidophilus, L. plantarum, B. lactis and S. boulardii was administered starting 1 day before operation and continuing for 15 days post operation. Patients were followed-up for 30 days with the development of postoperative complications as the primary outcome. PAXGene tubes and serum were collected on postoperative day 4 for measurement of gene expression and serum cytokines (ClinicalTrials.gov NCT02313519). Results Administration of P significantly decreased the rate of all postoperative major complications (28.6% vs. 48.8% of placebo, P = 0.010, odds ratio: 0.42). Major benefit was found in the reduction of the postoperative pneumonia rate (2.4% vs. 11.3%, P = 0.029), of wound infections (7.1% vs. 20.0%, P = 0.020), of anastomotic leakage (1.2% vs. 8.8%, P = 0.031) and of the need for mechanical ventilation (20.2% vs. 35.0%, P = 0.037). The time until hospital discharge was shortened as well. Gene expression of SOCS3 was positively related with circulating IL-6 in the P group but not in the placebo group (Figure 1). Conclusion The studied P formulation significantly decreased the risk of postoperative complications, namely mechanical ventilation, infections and anastomotic leakage. Modulation of the gene expression of SOCS3 is one suggested mechanism.