title: A Four-Probiotics Regimen Reduces Postoperative Complications After Colorectal Surgery: A Randomized, Double-Blind, Placebo-Controlled Study.
abstract: 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).
authors.affiliation: Department of Surgery, Aristotle University of Thessaloniki, Medical School, 54 635, Thessaloniki, Greece. kakothe@yahoo.com.
authors.forename: Katerina
authors.initials: K
authors.lastname: Kotzampassi
authors.affiliation: Department of Surgery, Aristotle University of Thessaloniki, Medical School, 54 635, Thessaloniki, Greece.
authors.forename: George
authors.initials: G
authors.lastname: Stavrou
authors.affiliation: 4th Department of Internal Medicine, University of Athens, Medical School, 124 62, Athens, Greece.
authors.forename: Georgia
authors.initials: G
authors.lastname: Damoraki
authors.affiliation: 4th Department of Internal Medicine, University of Athens, Medical School, 124 62, Athens, Greece.
authors.forename: Marianna
authors.initials: M
authors.lastname: Georgitsi
authors.affiliation: Department of Surgery, Aristotle University of Thessaloniki, Medical School, 54 635, Thessaloniki, Greece.
authors.forename: George
authors.initials: G
authors.lastname: Basdanis
authors.affiliation: Department of Surgery, Aristotle University of Thessaloniki, Medical School, 54 635, Thessaloniki, Greece.
authors.forename: Georgia
authors.initials: G
authors.lastname: Tsaousi
authors.affiliation: 4th Department of Internal Medicine, University of Athens, Medical School, 124 62, Athens, Greece.
authors.forename: Evangelos J
authors.initials: EJ
authors.lastname: Giamarellos-Bourboulis
mesh_terms: D000368:Aged; D057868:Anastomotic Leak / Q000517:prevention & control*; D001644:Bifidobacterium; D015179:Colorectal Neoplasms / Q000601:surgery*; D004311:Double-Blind Method; D057239:Early Termination of Clinical Trials; D005260:Female; D015870:Gene Expression; D006801:Humans; D015850:Interleukin-6 / Q000097:blood; D007779:Lactobacillus acidophilus; D048191:Lactiplantibacillus plantarum; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D011014:Pneumonia / Q000517:prevention & control*; D019936:Probiotics / Q000627:therapeutic use*; D012440:Saccharomyces; D000071223:Suppressor of Cytokine Signaling 3 Protein; D050826:Suppressor of Cytokine Signaling Proteins / Q000235:genetics; D013530:Surgical Wound Infection / Q000517:prevention & control*; D014409:Tumor Necrosis Factor-alpha / Q000235:genetics
chemical_list: D015850:Interleukin-6; C106644:SOCS3 protein, human; D000071223:Suppressor of Cytokine Signaling 3 Protein; D050826:Suppressor of Cytokine Signaling Proteins; D014409:Tumor Necrosis Factor-alpha