Probiotics, the potentially beneficial bacteria and yeasts available as diet supplements and in some foods, may not be as helpful as widely believed. A new study suggests that under certain circumstances, they can be deadly.
Researchers studied 296 patients at risk for severe pancreatitis, a potentially lethal inflammation of the pancreas. Each was randomly assigned to receive either a commercially available probiotic or an identical-looking placebo. All patients were otherwise given conventional treatment.
There was no significant difference between the two groups in severity of illness at the start of the trial. But while 31 percent of the probiotics group required intensive care, only 24 percent of the placebo group needed it. Eighteen percent of those who took probiotics, but only 10 percent of the others, required surgical intervention. In the probiotics group 24 people died, a death rate more than twice that of those given the placebo.
Several smaller studies have associated probiotics with a reduction of infections. But this study, published online Thursday in The Lancet, was the largest randomized, double-blinded trial of its kind, and the authors found no other reason for the harmful effects.
It will be interesting to see what happens with further research. Here's a response from a knowledgable industry-insider ...
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Last week it was announced that in a placebo-controlled probiotic+prebiotic study in acute pancreatitis patients, a rare and serious disease, 24 people died. The study by the University Medical Centre in Utrecht, Holland (UMC) was carried out between 2004 and 2007, after smaller tests had indicated that probiotics could help reduce the rate of infection in the pancreas.
Two hundred and ninety-six patients with acute pancreatitis took part in the study across 15 hospitals in the Netherlands. Twenty-four died in the study group and nine died in the control group.
Although this may appear worrisome to users of probiotics, this study conducted on intensivecare patients suggests that there are no implications for ordinary use of probiotics in food, beverage or dietary supplements.
In the experiment, the researchers added probiotics, as well as a fiber supplement, to the patients' drip-feed "in the expectation that it would boost the body's resistance to harmful bacteria", the UMC said in its press release. "The exact cause of the deaths is under investigation," the UMC stated, adding though that post-mortems had ruled out any possibility that the probiotics caused infection.
It is difficult to come to any conclusions because the causes of death have not been published. The following has been published about the study's protocol: "The administered material was Ecologic� 641 (Winclove Bio Industries, Amsterdam, The Netherlands) and fibre enriched tube feeding (Multifibre�, Nutricia, Zoetermeer, The Netherlands)....Ecologic� 641 consists of 6 strains of viable and freeze-dried bacteria, namely 4 lactobacilli: Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus salivarius, Lactococcus lactis, and 2 bifidobacteria: Bifidobacterium bifidum and Bifidobacterium lactis in a total daily dose of 1010 bacteria. The studyproduct is administered twice daily through a nasojejunal tube for a maximum of 28 days."
The directly administered (enteral) amount of bacteria was 20 billion CFU, half of it given twice per day. It is not known whether the patients died of bacteremia sepsis, but it is extremely doubtful that any of the probiotics would be a cause of sepsis per se and the protocol provided for the administration of appropriate antibiotics against the probiotics if they appeared in any of the patients' systems. Even if probiotics are present during sepsis, that would not mean they were the cause of the sepsis.
Diet Supplement Seen as Risky for Some Users
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