Sweden’s Probi says it has entered into a co-development agreement with “a leading global food company” as part of a bid to gain health claims approval for its ProbiDefendum immune health probiotic ingredient.
In conjunction with the unnamed company, Probi is to begin a clinical study early next year designed to prove the bacteria is effective in preventing infections of the upper respiratory tract, such as colds and flu.
Involving at least 300 subjects over a period of four months, the placebo-controlled, randomized, double-blind study will be specifically designed to satisfy the stringent requirements demanded by the European Food Safety Authority (EFSA), which is assessing all submissions made under the EU’s Nutrition & Health Claims Regulation.
Probi’s ProbiDefendum is currently available in a range of fruit juices sold in Swedish food stores under the brands Friscus and Bravo, as well as in chewable tablets sold through pharmacies and heath food stores in the Nordic region under the brand ProbiFrisk.
The company hopes that by teaming up with a major food business and securing a health claim in the EU, it will be able to launch products containing ProbiDefendum in new food categories.
Michael Oredsson, CEO of Probi, said: “I am very pleased that ProbiDefendum has attracted one of the global leaders in the food industry. We have jointly concluded that, provided that the new trial is also successful, Probi will be in a position to file a very strong application to EFSA, where the new trial will be added to our current clinical data.”
EFSA is yet to approve any health claims for probiotic bacteria—although most of those rejected so far were turned down because the micro-organism in the claim had not been properly "characterized."