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[Probiotic prophylaxis in patients with predicted severe acute pancreatitis: a randomised, double-blind,
M G H Besselink1, H C van Santvoort, E Buskens
1Afd. Heelkunde, Universitair Medisch Centrum Utrecht, Utrecht. m.besselink@umcutrecht.nl
Insights
Probiotic prophylaxis did not prevent infections in severe acute pancreatitis patients. This treatment significantly increased mortality and bowel ischemia, indicating it should not be used in this patient group.
Area of Science:
- Gastroenterology
- Critical Care Medicine
- Microbiology
Context:
- Severe acute pancreatitis (AP) is a critical condition with high morbidity and mortality.
- Infectious complications significantly worsen patient outcomes in severe AP.
- Enteral probiotics are explored for their potential to modulate gut microbiota and prevent infections.
Purpose:
- To investigate the efficacy of enteral probiotic prophylaxis in preventing infectious complications in patients with predicted severe acute pancreatitis.
- To assess the impact of probiotics on mortality and adverse events in this patient population.
Summary:
- A multicenter, randomized, double-blind, placebo-controlled trial involved 296 patients with predicted severe acute pancreatitis.
- Patients received either a multispecies probiotic preparation or placebo via jejunal catheter for 28 days.
- Probiotic use did not reduce infectious complications but was associated with a significant increase in mortality and bowel ischemia.
Impact:
- The findings suggest that this specific combination of probiotic strains is not beneficial and may be harmful in patients with predicted severe acute pancreatitis.
- Probiotic prophylaxis should not be administered to this patient group due to increased risks of mortality and severe adverse events.
- This study highlights the importance of rigorous clinical evaluation before widespread adoption of probiotics in critical care settings.
Objective:
To evaluate whether enteral prophylaxis with probiotics in patients with predicted severe acute pancreatitis prevents infectious complications.
Design:
Multicentre, randomised, double-blind, placebo-controlled trial.
Method:
A total of 296 patients with predicted severe acute pancreatitis (APACHE II score > or = 8, Imrie score > or = 3 or C-reactive protein concentration > 150 mg/l) were included and randomised to one of two groups. Within 72 hours after symptom onset, patients received a multispecies preparation of probiotics or placebo given twice daily via a jejunal catheter for 28 days. The primary endpoint was the occurrence of one of the following infections during admission and go-day follow-up: infected pancreatic necrosis, bacteraemia, pneumonia, urosepsis or infected ascites. Secondary endpoints were mortality and adverse reactions. The study registration number is ISRCTN38327949.
Results:
Treatment groups were similar at baseline with regard to patient characteristics and disease severity. Infections occurred in 30% of patients in the probiotics group (46 of 152 patients) and 28% of those in the placebo group (41 of 144 patients; relative risk (RR): 1.1; 95% CI: 0.8-1.5). The mortality rate was 16% in the probiotics group (24 of 152 patients) and 6% (9 of 144 patients) in the placebo group (RR: 2.5; 95% CI: 1.2-5.3). In the probiotics group, 9 patients developed bowel ischaemia (of whom 8 patients died), compared with none in the placebo group (p = 0.004).
Conclusion:
In patients with predicted severe acute pancreatitis, use of this combination of probiotic strains did not reduce the risk of infections. Probiotic prophylaxis was associated with a more than two-fold increase in mortality and should therefore not be administered in this category of patients.
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