Dutch probiotics study is criticised for its “design, approval, and conduct”BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c77 (Published 06 January 2010) Cite this as: BMJ 2010;340:c77
- Tony Sheldon
A joint investigation by three Dutch authorities has criticised the preparation and execution of a study of the use of probiotics in patients with acute pancreatitis.
Their two year investigation was launched (BMJ 2008;336:296-7, doi:10.1136/bmj.39482.327350.C2) after it emerged that the mortality rate among the trial participants who had received the probiotics preparation was higher (24 of 152 participants died) than that among those who had received a placebo (nine of 144).
The Dutch Healthcare Inspectorate, the Central Commission on Research involving Human Participants, and the Food and Consumer Product Safety Authority now conclude that the study’s design, approval, and conduct had “major shortcomings.” Their …