“We can’t at this stage say who they are or what the exact arrangement is but they are very much involved in this,” chief executive officer Michael Oredsson told NutraIngredients this morning.
‘This’, to begin with, is a clinical trial on the ProbiDefendum strain that is utilised in probiotic juices Friscus/Bravo sold in Sweden, as well as chewable tablets sold in the Nordic region under Probi’s own brand, ProbiFrisk.
That trial will commence at the beginning of 2012 and is due to run for four months, after which it will be added to an article 13.5, proprietary, immune health dossier that will be sent to the European Food Safety Authority (EFSA) for assessment under the EU nutrition and health claims regulation (NHCR) at some point in 2012.
“So there has been a lot of intelligence gathering and we are reasonably confident we have what EFSA wants,” Oredsson said, noting the application would be made under the Probi name, with the food giant remaining a silent partner for the foreseeable future.
The planned study
The four-month immunity study will be a placebo-controlled, randomised, double-blind study with at least 300 subjects. Its focus will be the reduction of upper respiratory tract infection symptoms.
Secondary endpoints including the impact of ProbiDefendum versus placebo on a number of immune markers will also be studied.
“EFSA has stated that the combination of data on infections and on immune markers is particularly relevant in the case of immune defence,” the company said.
Oredsson said another study was already underway for its LV99 strain testing for irritable bowel syndrome relief in Denmark that was set to conclude before the end of 2011.
He said the regulatory ambiguity surrounding probiotics had not affected the company’s business, where food supplements revenue had grown 114% year on year to Q3 this year. Overall revenue growth was around 30%.
“Outside of Europe there is less health claim concern, especially in the US and Asia.”
MICROBIOTA 2011
The latest knowledge and industrial applications in human microflora including probiotics will be discussed at the MICROBIOTA two-day conference in Paris on December 13-14, 2011. For more information click here.