Infectious complications and associated mortality are a major concern in acute pancreatitis.
Enteral administration of probiotics could prevent infectious complications, but convincing evidence is scarce.
Professor Hein Gooszen and colleagues from the Netherlands assessed the effects of probiotic prophylaxis in patients with predicted severe acute pancreatitis.
|Infectious complications occurred in 30% patients in the probiotics group|
The team conducted a multicenter randomized, double-blind, placebo-controlled trial.
The researchers identified 298 patients with predicted severe acute pancreatitis within 72 hours of onset of symptoms.
The research team randomized 153 to receive a multispecies probiotic preparation, and 145 to placebo, administered enterally twice daily for 28 days.
The primary endpoint was the composite of infectious complications, including infected pancreatic necrosis, bacteremia, pneumonia, urosepsis, or infected ascites, during admission and 90-day follow-up.
Analyses were by intention to treat.
The researchers excluded 1 person in each group from analyses because of incorrect diagnoses of pancreatitis.
Subsequently, 152 individuals in the probiotics group and 144 in the placebo group were analyzed.
The team found that the groups were much the same at baseline in terms of patients' characteristics and disease severity.
The team observed infectious complications in 30% patients in the probiotics group.
Infectious complications occurred in 28% of those in the placebo group.
The researchers noted that 16% of patients in the probiotics group died, compared with 6% in the placebo group.
The team noted that 9 patients in the probiotics group developed bowel ischemia, compared with none in the placebo group.
Professor Gooszen's team concluded, "In patients with predicted severe acute pancreatitis, probiotic prophylaxis with this combination of probiotic strains did not reduce the risk of infectious complications, and was associated with an increased risk of mortality."
"Probiotic prophylaxis should therefore not be administered in this category of patients."