Collaboration among stakeholders needed for probiotics research to move forward, experts say

On the uncertainty side, presenters at the event, hosted by NutraIngredients-USA, said that FDA’s guidance on Investigational New Drugs continues to be a source of difficulty. Without a definition of what a “healthy” gut is, how can companies move forward in seeking to show a benefit for their probiotics without triggering the need for an IND filing and all the complications that come with that?  Up to now, the field has tiptoed around the issue, designed studies nipping at the edges of the problem that seek to advance the scientific base without setting of an IND tripwire. It’s time for that confusing process to end, said Dr Susan Mitmesser, PhD, director of nutrition research for supplement manufacturer NBTY. She called for collaboration among all the stakeholders, including regulators, academics and manufacturers, to find a clearer, more rational path forward.

“My hope for the future is that everybody can leave their preconceived notions at the door, come to the table and have open, collaborative discussions, discussions that lead to more robust products,”​ Mitmesser said.

Good news on science front​

Despite the regulatory difficulties, researchers have been moving forward in the realm of pure science. Dr David Sela, PhD,  an assistant professor in food science at the University of Massachusetts Amherst, said new technologies that have come online in recent years have allowed researchers to get a better handle on the individual organisms’ internal mechanics.

“We have had a lot of technology that has come online in just the last ten years that has been really enabling,”​ he said. “We are able to ask questions to really understand what’s going on with the bugs’ physiology and how that is affecting human health.”​

Dr Emeran Mayer, MD, director of the  Oppenheimer Family Center for Neurobiology of Stress at UCLA, called for more high quality, large scale studies to validate earlier research that shows that probiotic organisms do indeed have a physiological effect in the human body.

“I think the best parameter to measure is the brain,” ​he said.  

But Mayer cautioned that the field is at a bit of a crossroads. Without a new raft of such high quality studies, the field could slip backwards and start resting on the laurels of earlier studies that, while promising, don’t offer sufficient scientific underpinning.

“Without those studies I think this field could kind of deteriorate into kind of a pseudoscience, with a totally commercially driven agenda, and I think that would be a shame if that happened,”​ he said.