Exposing healthy people to modified pathogens in a controlled clinical trial setting could be an exciting new way for industry to overcome the challenges of health claim substantiation, says Nizo Food Research expert.
Probiotics have been a hot topic of late, with attempts to gain EFSA approved health claims causing a number of headaches for the sector.
However, Alwine Kardinaal, senior researcher for health and nutrition at Nizo Food Research believes new challenge models that expose healthy participants to modified versions of pathogens show great promise in elucidating the positive health effects of probiotics.
“EFSA does not accept that there are good or bad bacteria, but they do accept that claims should focus on resistance against pathogens,” explained Kardinaal. “The problem is that there are not very good markers for this.”
“What is necessary to substantiate a claim in this area is to look at clinical symptoms caused by pathogens, and that is not an easy answer.”
“you need people to get infected”
Kardinaal said that one of the key challenges for industry is that they need to be able to show a positive effect in the target population for the product that will bear the claim – healthy people.
“That means that you need people to get infected,” she said. “There are a number of models that you can think of to do the trick.”
The Nizo expert said while models of spontaneous infection can work, in which people who may be more likely to become ill often are studied, there is an issue with the spontaneous nature of the infections that may occur.
“The problem with such studies is that you don’t know upfront who is going to get infected and who is not. So these typse of studies require quite a large number of study participants which makes them relatively expensive and complex.
A potential solution to this, she noted, is to perform what is essentially a randomised clinical trial by exposing healthy individuals to a pathogen in a controlled way.
“That is a model that we have used in a number of situations,” said Kardinaal. “It can be used to show effects on resistance against pathogens of probiotics, prebiotics, but other ingredients as well.”