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Probioticaprofylaxe bij voorspeld ernstige acute pancreatitis: een gerandomiseerde, dubbelblinde, placebogecontroleerde trial

Besselink, M. G. H., Santvoort, H. C., Buskens, E., Boermeester, M. A., van Goor, H., Timmerman, H. M., Nieuwenhuijs, V. B., Bollen, T. L. & Ramshorst, B. V., 2008, In : Nederlands Tijdschrift voor Geneeskunde. 152, p. 685-696 12 p.

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  • M.G.H. Besselink
  • H.C. Santvoort
  • E. Buskens
  • M.A. Boermeester
  • Harry van Goor
  • H.M. Timmerman
  • V.B. Nieuwenhuijs
  • T.L. Bollen
  • B.van Ramshorst
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.
Original languageEnglish
Pages (from-to)685-696
Number of pages12
JournalNederlands Tijdschrift voor Geneeskunde
Volume152
Publication statusPublished - 2008

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