Randomized Trial of Perioperative Probiotics among Patients Undergoing Major Abdominal Operation

Abstract BACKGROUND We investigated the utility and safety of short-course oral probiotics among patients undergoing major abdominal surgery. Perioperative probiotics may decrease length of stay and lower rates of infectious complications. We assessed whether perioperative probiotics decrease major complications among high-risk gastrointestinal surgery patients in a pragmatic randomized trial. METHODS This double-blind trial randomized 135 patients undergoing elective major gastrointestinal surgery to perioperative oral probiotic VSL#3 taken just before operation and twice daily up to 15 total doses (n=67) or placebo (n=68). The primary outcome measure was 30-day composite outcome of death, unplanned readmission, or any infection. RESULTS Primary outcome occurred amongst 17 patients in the placebo group (25.0%) versus 22 patients in the probiotic group (32.8%, p=0.315). Thirty-day mortality was 2 (2.9%) in placebo group as compared to 1 (1.5%) in probiotic group (p=1.000). Placebo group patients experienced lower 30-day readmission rate (3/68, 4.4%) as compared to probiotic group (11/67, 16.4%; p=0.022). None of the placebo patients were readmitted for dehydration, but 5 of 11 probiotic group patients (45%, p=0.049) were readmitted for dehydration as a consequence of diet intolerance and/or diarrhea. There was no difference in 30-day infection rate between the groups (15/68, 22% in placebo versus 15/67, 22.4% in probiotic group, p=0.963). CONCLUSION Perioperative use of VSL#3 probiotic did not affect 30-day composite outcome of mortality, readmission and infection rate. A significantly higher readmission rate was observed among those exposed to probiotics. Further studies remain warranted.