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In patients with acute pancreatitis — particularly those who develop pancreatic necrosis — infectious complications are a major cause of morbidity and mortality. Two recent randomized studies and two meta-analyses failed to demonstrate a benefit of prophylactic antibiotics in preventing infection among such patients. Now, researchers in the Netherlands have conducted a multicenter, double-blind trial involving 296 adults with acute pancreatitis and a predicted severe course of disease to determine whether probiotics might be useful.
Participants were randomized to receive a multispecies probiotic preparation or placebo, administered enterally (by nasojejunal feeding tube) twice daily for up to 28 days, beginning within 72 hours after symptom onset. A contrast-enhanced computed tomography scan was performed 7 days after admission to detect pancreatic necrosis.
Incidence of infectious complications (i.e., infected pancreatic necrosis, bacteremia, pneumonia, urosepsis, or infected ascites, detected within 90 days of admission) was similar between the probiotics group and the placebo group (30% vs. 28%; relative risk, 1.06; 95% CI, 0.75–1.51). The 90-day mortality rate was higher in the probiotics group (16% vs. 6%; P=0.01), with most of the deaths (82% overall) due to multiorgan failure. Bowel ischemia developed in nine probiotics-group patients (8 of whom died) but no placebo-group patients (P=0.004). Among individuals with pancreatic necrosis (46 in the probiotics group and 34 in the placebo group), probiotics recipients appeared to have a higher rate of infectious complications than did placebo recipients, but the difference was not statistically significant (70% vs. 53%; P=0.16); in any case, probiotics recipients did have a significantly higher mortality rate (41% vs. 15%; P=0.01).
Besselink MGH et al. Probiotic prophylaxis in predicted severe acute pancreatitis: A randomised, double-blind, placebo-controlled trial. Lancet 2008 Feb 23; 371:651.
Comment
This randomized, double-blind, placebo-controlled trial involving patients with predicted severe acute pancreatitis showed no beneficial effect of probiotic prophylaxis on the occurrence of infectious complications. In fact, probiotics were associated with higher rates of multiorgan failure, bowel ischemia, and mortality. Thus, probiotics (at least the combination of strains used in this study) should not be used in patients with acute pancreatitis.