25 January 2008 - The University Medical Center Utrecht (UMCU) has published the results of a 3-year-long study carried out to test the effectiveness of probiotics at reducing acute pancreatitis.
After finding out during smaller tests that probiotics could help reduce the rate of infection in the pancreas, the UMCU researchers carried out a large study between 2004 and 2007 in 15 Dutch hospitals on 296 patients with acute pancreatitis.
Acute pancreatitis is a rapidly-onset inflammation of the pancreas. Depending on its severity, it can have severe complications and high mortality despite treatment.
24 patients (16%) in the study group died completely unexpectedly and 9 patients (6%) in the control group. Therefore more people died in the group that was given probiotics than in the group that was not.
The investigators were surprised by the outcome as the previous small-scale trials showed that the treatment would normally reduce the rate of infection.
The names of the bacteria strains, which were used in the treatment, were not disclosed by the UMCU.
According to the researchers, who do not yet know what caused the higher death rate, 3 factors may have played a role: - the administration of probiotics in the acute phase of this serious disease, - the administration of probiotics to intensive-care patients, and, - the administration of probiotics through a feeding tube (directly into the intestine).
Further to this discovery, the investigators have issued advise to colleagues not to use probiotic bacteria in situations that meet one (or more) of the 3 factors.
In a statement, the UMCU said: “The study’s finding did not emerge until after the study was completed. This is because it was conducted ‘double blind’, as is required in medical research. Halfway through the study, a specially created monitoring commission established that there were no significant differences, neither in the infection rate nor in the risk of death. The total death rate during the study period was 11 percent, which is not significantly higher than the 10 percent that is known from medical literature. This is why during the study period the strong difference between patient groups went unnoticed. The differences between the two patient groups did not become visible until a code was broken after completion of the study. All the participating patients gave prior consent to take part in the study and all the guidelines of the Central Committee on Research Involving Human Subjects (CCMO) were followed”.
PROBIOTIC PRODUCERS' RESPONSE
The European Food and Feed Cultures Association (EFFCA), which represents the manufacturers of probiotic strains, reacted quickly by saying it is paying “serious attention” to the study and will “await its official publication in order to obtain a more thorough picture and deeper insight in the details behind it”. However, the association did stress the fact that acute pancreatitis patients have a high mortality rate anyway.
“EFFCA notes that the researchers did not expect the actual conclusion of the study and are not able to explain the reason behind the higher mortality ratio in the group of patients treated with probiotics. EFFCA looks forward to any further analysis that can clarify this”, the association said in a statement.
EFFCA went on to say that the findings of the study have NO implications for the ordinary use of probiotics in food, beverage or dietary supplements. Furthermore, the probiotic strains manufactured by its members have a long history of safe use both in food and dietary supplements and have been assessed in terms of safety studies.
“To our knowledge, probiotic clinical studies had never resulted in the degradation of the health condition before. On the contrary, many health promoting benefits from probiotics have been scientifically demonstrated”, EFFCA added.
Meanwhile, the Dutch Food Safety Authority (VWA) also said that there was no reason for alarm and also stressed that probiotics do not have any negative effects on healthy people.