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A Four-Probiotics Regimen Reduces Postoperative Complications After Colorectal Surgery: A Randomized, Double-Blind, Placebo-Controlled Study
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A Four-Probiotics Regimen Reduces Postoperative Complications After Colorectal Surgery: A Randomized, Double-Blind, Placebo-Controlled Study
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A Four-Probiotics Regimen Reduces Postoperative Complications After Colorectal Surgery: A Randomized, Double-Blind, Placebo-Controlled Study
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Journal Article
A Four-Probiotics Regimen Reduces Postoperative Complications After Colorectal Surgery: A Randomized, Double-Blind, Placebo-Controlled Study
2015
Overview
Background
Heterogeneous results of published studies led to conduct a randomized clinical trial to assess the efficacy of a new formulation of four probiotics as prophylaxis for complications after colorectal surgery.
Methods
A double-blind, placebo-controlled randomized study was conducted enrolling patients undergoing colorectal surgery for cancer. Capsules of placebo or of a formulation containing
Lactobacillus acidophilus
,
L. p
lantarum
,
Bifidobacterium lactis
and
Saccharomyces boulardii
were administered starting one day before operation and continuing for another 15 days postoperatively. Patients were followed up for 30 days with the development of postoperative complications as the primary outcome. Gene expression and serum levels of cytokines were measured on postoperative day 4 (
www.clinicaltrials.gov
NCT02313519).
Results
The study was prematurely stopped after enrolment due to efficacy in the primary outcome. Administration of probiotics significantly decreased the rate of all postoperative major complication (28.6 vs. 48.8 % of the placebo arm,
p
0.010, odds ratio 0.42). Major benefit was found in the reduction of the rate of postoperative pneumonia (2.4 vs. 11.3 %,
p
0.029), of surgical site infections (7.1 vs. 20.0 %,
p
0.020) and of anastomotic leakage (1.2 vs. 8.8 %,
p
0.031). The time until hospital discharge was shortened as well. Gene expression of
SOCS3
was positively related with gene expression of
TNF
and of circulating IL-6 in the probiotic group but not in the placebo group.
Conclusions
The studied probiotic 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 (
www.clinicaltrials.gov
NCT02313519).
Publisher
Springer International Publishing,John Wiley & Sons, Inc
Subject
/ Aged
/ Anastomotic Leak - prevention & control
/ Colorectal Neoplasms - surgery
/ Early Termination of Clinical Trials
/ Female
/ Humans
/ Male
/ Medicine
/ Pneumonia - prevention & control
/ Probiotics - therapeutic use
/ Suppressor of Cytokine Signaling 3 Protein
/ Suppressor of Cytokine Signaling Proteins - genetics
/ Surgery
/ Surgical Wound Infection - prevention & control
