Hospital says some might have lived

It's been revealed that at least 24 people have died after taking part in research into a new treatment for pancreatitis being run at major Dutch hospitals. The University Medical Centre in Utrecht, which spearheaded the trials, announced today that the patients died between 2004 and 2007 during the research. Tests were carried out on a total of 296 patients in 15 hospitals across the country.

The research itself centred on the effect of probiotics in slowing inflammation of the pancreas in seriously ill patients.

Probiotics are living bacteria that are used in the treatment of intestinal complaints. A spokesman for the Utrecht hospital said a number of the patients involved might still have been alive had they not been given the bacteria.

Cause unknown

At this stage it is not clear what the exact cause of the deaths was. But in a comparable group of patients undergoing conventional treatment, so not using probiotics, only nine people died, so 15 more people died under the trail. Doctors involved in the trial admitted to being shocked by the difference in the mortality rates. The government's National Health Inspectorate is investigating the case.

The bacteria involved are varieties of Lactobacillus, Enterococcus, or Bifidobacterium. Probiotic bacteria are also used in freely available health foods and yoghurt drinks. The probiotics used for the tests had been supplied by Winclove, a Dutch company specializing in the production of probiotic food supplements.

Researchers at the Utrecht teaching hospital say that no unorthodox procedures were followed during the trials. They added that results of earlier and smaller tests in other countries had shown that administering probiotics would lessen inflammations of the pancreas.


Before submitting themselves to the trials, all the patients had signed a declaration confirming their willingness to participate. The hospital says it is too early to say whether relatives of the victims will be entitled to compensation.

A similar research project in the Czech Republic was halted in October 2007, when Dutch researchers raised doubts over the safety of the probiotics testing.

Death rate

With 24 out of the 296 test patients having died, the death rate is some 10 percent, which is highly unusual in tests of this kind. CenterWatch, a US-based trials information clearing house, quotes an average of one death per study subject, which means less than one fatality per clinical trial.

A test of anticoagulants at the same Utrecht teaching hospital in 1996, in which 651 patients took part, was halted when 17 of them died.

It is quite common for patients to suffer adverse effects during clinical trials, but these are rarely fatal. During a drug trial at a London hospital in March 2006, six healthy volunteers were injected with monoclonal antibodies. Within hours they became violently ill, suffering multiple organ failure and having to be admitted to intensive care. They all survived the ordeal.