24 lives lost in Dutch scientific study

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24 Dutch patients died between 2004 and 2007 in a Dutch scientific study into the effects of probiotics on slowing pancreatic infection.

23 January 2008

UTRECHT – 24 Dutch patients died between 2004 and 2007 in a Dutch scientific study into the effects of probiotics on slowing pancreatic infection.
The University Medical Centre Utrecht (UMC) announced this on Wednesday.

The hospital says that a number of those who died may still be alive if they had not been administered the probiotics. The hospital cannot say how many people could have survived.

Probiotics are beneficial intestinal bacteria that counter the growth of harmful bacteria. A total of 296 people took part in the study. They were treated in 15 Dutch hospitals, including all eight of the University Medical Centres.

The relatives were informed on Tuesday about the course of the study. The UMC says that the researchers are very upset. On the basis of small scale studies abroad they had expected the probiotics to diminish the infection.

A spokesperson for the UMC could not say on Wednesday whether the relatives could be eligible for damage compensation.

All the patients who took part in the study signed an agreement. Nothing went wrong in the study in and of itself, the spokesperson said. "The outcome was just more dramatic than expected."

The researchers realised in October last year that the probiotics could cause damage. The spokesperson said that colleagues in the Czech Republic carrying out a similar study were immediately alerted and the study there was stopped.

The UMC spokesperson said that probiotics are also contained in products like Yakult, which are on sale in supermarkets. The products reportedly help the functioning of the intestines.

The spokesperson does not expect that probiotics could cause any harm to healthy people. "But seriously ill patients in intensive care should not use them."

Biotechnology company Winclove, which supplied the probiotics for the study, says it is "upset" at what happened.

"We follow the advice of the researchers, in certain circumstances we no longer use the product," says director of the Amsterdam-based company Luuk van Duijn. Van Duijn refers to three situations in which the nutritional supplement can be dangerous: to people with organ failure, people in intensive care, and use with drip feeding.

"We are currently not working with any studies in which these three conditions are a factor ", Van Duijn said.

Van Duijn stressed that probiotics is a collective name for nutritional supplements that all have different properties. "We developed this particular product together with the hospital, with specific properties. The substance was only used in this particular trial." Other probiotics used in other circumstances do not necessarily have a harmful effect, Van Duijn said. "As far as we know now."

Yakult finds it unfortunate that the UMC spokesperson cited the product as one containing probiotics. "We are not happy about that," said a spokesperson for Yakult Nederland. The company does not plan to pursue the matter further however.

The spokesperson stressed that Yakult has nothing to do with the scientific study into the effect of probiotics on slowing gall bladder infection.

In the UMC study probiotics were introduced directly into the intestines of seriously ill patients via a drip. "That is a tricky business of course and it is very different from drinking a little bottle of Yakult."

The spokesperson said that probiotics is a broad term for living micro-organisms that have a beneficial effect on the intestines. The category includes lactic acid bacteria, but also microbiological nutritional supplements like yeast. Other products that contain different types of probiotics are Vifit, Actimel and Activia.

Yakult has never carried out any studies into the product's effect on people with serious gall bladder infection. The company sees no reason to do so.

It has conducted research into the product's effect on sick children, and others. "The safety of our product is not at all up for discussion in the scientific world."

[Copyright Expatica News + ANP 2008]

Subject: Dutch news

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