Healthy Skepticism Library item: 12766

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Publication type: Journal Article

Sheldon T.
Dutch trial of probiotics in acute pancreatitis is to be investigated after deaths
BMJ 2008 Feb 9; 336:(7639):296-7
http://www.bmj.com/cgi/content/extract/336/7639/296-b?etoc

Abstract:

A Dutch trial of probiotics in acute pancreatitis that resulted in 15 unexpected deaths is being investigated by the Dutch Healthcare Inspectorate and the Central Committee on Research involving Human Subjects.

The multicentre, double blind, randomised controlled trial was designed to see whether probiotics could reduce the incidence of infectious complications in patients with severe acute pancreatitis. Previous small scale studies had indicated that probiotic treatment might be effective (British Journal of Surgery 2002;89:1103-7).

The Dutch trial involved nearly 300 patients in 15 hospitals, including all of the Netherlands’ eight university medical centres. The protocol had been approved by ethics committees, and the participants had all given informed written consent.

The study compared the use of a multispecies probiotic preparation with a placebo. The results showed that infectious complications occurred in 30% of the participants who were treated with the probiotic preparation and in 29% in the placebo group. . .