Chr Hansen eyes first EFSA probiotic approval with uber-“pharma-style” immune study
The trial splits 1058 healthy people into L. casei and control groups and uses an influenza vaccination model to determine the probiotic's effectiveness in battling influenza and other viral respiratory tract infections (VRTI).
The pharma-style of trial design favoured by the European Food Safety Authority (EFSA) has been closely followed.
“We have been researching our probiotic strains for a long time but our clinical programme has become more ambitious since the EU nutrition and health claims regulation (NHCR) came into place,” Chr Hansen spokesperson Ulrik Soendergaard told NutraIngredients today.
Influenza-related health costs are estimated to be in the 100s of billions of euros globally, and Chr Hansen was keen to emphasise the trial's global focus.
While Danone, Yakult, Danisco and other probiotic players have conducted large-scale trials, Soendergaard said this one was the largest of its kind using the influenza vaccination model, and immunity and gut health guidance issued by EFSA earlier this year had played its part in the trial design.
Pharma-style
The company’s director of scientific affairs in its Health & Nutrition Division, Birgit Michelsen, said the trial would build on recently published studies in sources like 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,” she said.
“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.”
On trial
The study is conducted in collaboration with the Department of Human Nutrition, Faculty of Life Sciences at the University of Copenhagen, Denmark, alongwith the German contract research organisation, Harrison Clinical Research.
Lead researcher is the Uni of Copenhagen’s Professor Lars O Dragsted who commented: “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 study is recruiting healthy 18-60 year-old men and women in Germany and Denmark until the end of November, 2011, and is expected to complete in April, 2012.
Further details about it can be found here.
