Link to causality: Industry needs to up prebiotic & probiotic efforts

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Clinical trials investigating the effects of prebiotics and probiotics on the microbiome have to move from an association to causation if the market is to evolve in the long-term.

Taking part in the Future Food Tech conference in London last week, Colette Shortt, global regulatory director at Johnson & Johnson, said that while this shift could take time, current research had to move away from association studies to more the double-blind placebo-controlled clinical trial to really prove efficacy.

“There are a range of products, from Faecal Microbiota Transplantation (FMT) to standard food products that modulate the microbiome,” she explained.

“With the example of FMT, this has happened quite rapidly. I think it does show that there are real effects but the studies need to be done. However, there are a lot of opportunities there, particularly in ordinary and medical foods.”

Also taking part in the session was Rob Beudeker, vice president of innovation, Human Nutrition and Health at DSM. He echoed her comments adding that current studies generate much data but little in the way of causality and eventual health benefits.

“It’s an extremely complex issue,” he added. “It’s not only the microbiome; it’s the individual’s genes, and their behaviour. There are a lot of aspects that need to be taken into account.”

Beudeker made reference to DSM’s research in the prebiotic abilities of riboflavin and its multifaceted role in the human intestine. 

“We have recently been able to demonstrate the abilities of riboflavin as an electron acceptor as used by microorganisms contained in faecal bacteria.”

“Just changing the dosage of riboflavin, you can change the composition of the microbiome in the colon. We now need to make that link between those results and the health benefits.”

A business model for the microbiome

Scott Parkinson, head of Gastro-Intestinal Health & Microbiome, at Nestlé Institute of Health Sciences, attempted to move away from the science side and highlighted an incompatible business model as restrictive in prebiotic and probiotic research.

“A research-heavy industry like pharmaceuticals is based on large investments upfront and through the clinical trial process. Strong returns are almost guaranteed through their intellectual property (IP) rights on the final product.”

“I don’t know if this business model works for the microbiome. I think if you’re thinking about breaking patents, there are a lot of risks for the business in going down this route. I think for a lot of companies, it may be that they are moving from an IP-based business to an emphasis on know-how, how things work together and getting the right people in place.”

He described the different levels of expertise required in the success of a product and going down a specific health route.

“Marketing is one level,” he commented. “If you’re looking to market a product and you want to find some evidence to support a health claim. That’s one kind of expertise that needs considering.”

“You also need the right people to obtain the right preliminary findings and to get the product through the process to demonstrate the effects in clinical trials. Here individuals specialising in the regulatory process is another consideration.”

‘EFSA opinions not insurmountable’

Current European regulation for prebiotics and probiotics focus very much on cause and effect. To complicate matters the European Food Safety Authority (EFSA) has been criticised for not being clear enough in its scientific gudelines and requirements in the area.

“The area in Europe is less clear as there are no therapeutic guidelines,” said Shortt. “To date we have not seen any probiotic-related claims coming through. I imagine we will quite soon particularly with prebiotics.”

“I think there is a need to integrate the clinical programmes with the regulatory strategy. In the past studies were done without a regulatory end point in mind. I think to include this now in the development phase is very important because of the added complexity of experimenting with live bacteria.”

“If you evaluate the opinions given by EFSA, particular for general health claims, they’re not insurmountable.”

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