Clinical trials result in 24 deaths

Clinical trials involving measures to reduce an acute infection of the pancreas have left 24 patients dead, Utrecht university’s teaching hospital said on Wednesday.

The nationwide research led to an ‘unexpectedly higher death rate’ among those being treated with involving probiotics compared with the control group, the hospital said.
In total 296 people took part in the government-funded trials at 15 Dutch hospitals, including all eight university medical centres.
Nine patients (6%) in the control group died compared with 24 (16%) in the group which were treated with probiotics. The trials took place between 2004 and 2007.
Probiotics, often used in food supplements, are bacteria or yeasts which are said to combat the growth of harmful bacteria in the gut.
Foreign research had indicated that probiotics do reduce pancreatitis, a rare and extremely serious disease which affects some 3,000 people in the Netherlands a year, the university said.
During the research patients were given probiotics via drip feeds in the hope this would boost their resistance to harmful bacteria.
Research is now continuing into the likely cause of the higher death rate, the university said.
In the meantime, doctors are being recommended not to give probiotics to patients with organ failure, those in intensive care or being drip-fed.
A spokeswoman for Utrecht medical centre said all those who took part in the research had given their written consent.
Nothing had gone wrong with the actual research, the NRC reported her as saying. ‘Only the result is dramatically different than expected.’

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