Probiotics are associated with an increased mortality in patients with severe acute pancreatitis, and do not reduce the risk of infectious complications in these patients. These are the conclusions of authors of an Article published early Online and in an upcoming edition of The Lancet.
Infectious complications and associated mortality are a major concern in acute pancreatitis. Around a fifth of patients with this disease have necrotising pancreatitis, which has a 10-30% mortality rate largely due to infectious complications. These complications are thought to start with overgrowth of small-bowel bacteria. Researchers have previously suggested that prophylaxis using strains of probiotic (‘good’ bacteria) might prevent infectious complications by reducing this small-bowel bacterial overgrowth -- thereby restoring gastrointestinal barrier function, and modulating the immune system.
Professor Hein Gooszen, University Medical Center Utrecht, Netherlands, and colleagues, did a randomised, double-blind, placebo controlled trial of 296 patients with predicted severe acute pancreatitis -- 152 in the probiotics group, and 144 in the placebo group. The patients in each group were similar in terms of characteristics and disease severity. Each of the patients was randomly assigned within 72 hours of onset of symptoms to receive a multispecies probiotic preparation* or placebo, administered enterally** twice daily for 28 days. All were monitored for the occurrence of infectious complications -- ie, infected pancreatic necrosis, bacteraemia, pneumonia, urosepsis, or infected ascites*** -- during both admission and 90 day-follow-up.
They found that the proportions of patients having infectious complications was similar in both groups -- 46 patients (30%) in the probiotics group and 41 (28%) in the placebo group. However, in the probiotics group many more of these patients died -- 24 (16%), versus nine (6%) in the placebo group. Nine patients in the probiotics group developed bowel ischaemia -- eight with fatal outcome -- compared with none in the placebo group.
The authors say: "Our findings show that probiotics should not be administered routinely in patients with predicted severe acute pancreatitis, and that the particular composition used here should be banned for the present indication. Whether other combinations of strains might have resulted in different results is debatable, but, until the underlying mechanism is actually revealed, administration of probiotics in patients with predicted severe acute pancreatitis must be regarded as unsafe.
"Most importantly, probiotics can no longer be considered to be harmless adjuncts to enteral nutrition, especially in critically ill patients or patients at risk for non-occlusive mesenteric ischaemia."****
Notes to editors:
*For the full composition of the probiotic combination used in this study, see p2, column 2 of full paper.
**Enterally means given directly via the digestive tract -- the patients in this study were fed their probiotics or placebo via a feeding tube, or orally after having it dissolved in water.
***Ascites is an accumulation of fluid in the peritoneal cavity of the abdomen; urosepsis is a serious urinary-tract infection
****Mesentric ischaemia is when inflammation and injury of the small intestine result from inadequate blood supply
University Medical Center Utrecht, Department of Corporate Communication, press officer Ilse van Wijk, T) +31 88 7556371. E) I.vanwijk-5@UMCUtrecht.nl / h.gooszen@umcutrecht.nl
Journal
The Lancet