Unprecedented large-scale clinical study to further document the immune-boosting properties of Chr. Hansen’s probiotics

Influenza and other viral respiratory tract infections (VRTI) such as the common cold affect a vast number of people every year, representing a significant societal health issue with massive economic costs.

In the US alone, approx. 500 million non-influenza-related VRTI episodes occur per year. The total economic impact of treating these infections approaches $40 billion annually (note #1). Further, the annual influenza epidemics in the US result in an average of direct medical costs of $10.4 billion annually, and the total economic burden of annual influenza epidemics amount to $87.1 billion (note #2).

The role of probiotics in immune health
Using an influenza vaccination model, Chr. Hansen’s new study involving 1058 healthy adult participants will investigate how the consumption of ‘L. casei 431^®’—one of Chr. Hansen’s flagship probiotic strains—will support healthy people’s immune system in fighting off viral respiratory tract infections.

“Chr. Hansen’s probiotic portfolio is already among the best scientifically documented in the world, and very recently an immune study with remarkable findings was published in the British Journal of Nutrition. The study which we are now initiating will significantly improve the scientific evidence of the immune health benefits of our probiotics in healthy people,” says Chr. Hansen’s Birgit Michelsen, Director of Scientific Affairs, Health & Nutrition Division. “The study stands out by being very large, by involving healthy people, and by taking advantage of using the same standards and quality tools as pharmaceutical studies.”

A multi-center approach
The study is conducted in collaboration with the Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen, Denmark, and the Harrison Clinical Research in Munich, Germany, a contract research organization. Professor Lars O. Dragsted who heads up the University of Copenhagen’s research team involved in the study, says: “We are exceptionally pleased and proud to be collaborating with Chr. Hansen on this prestigious study. Carrying this unusually large and ambitious study through requires clinical excellence and we expect it to add significant new evidence to the research area and also benefit the University of Copenhagen as a trusted and competent academic partner.”

The multi-center, randomized, placebo-controlled, parallel-group study clinical study is recruiting participants from September to November 2011. The details about the study called "The effect of Lactobacilli on the immune system of healthy adults" are available at the ISRCTN register of current controlled trials:
http://www.controlled-trials.com/ISRCTN08280229

Note #1: Source: Fendrick et al. The economic burden of non-influenza-related viral respiratory tract infection in the United States. Arch Intern Med 2003;163:487-494 (2001 numbers)
Note #2: Source: Molinari et al: The annual impact of seasonal influenza in the US: Measuring disease burden and costs. Vaccine 2007 (2003 US population)