“I think we are not proud enough of the science that we have in the probiotic field,” Dr Jessica Terhaar (née Younes) told us at the recent SupplySide West show in Las Vegas. “If you split up safety and efficacy, there’s a lot of science that goes behind both of them.
“Take the safety question: Good manufacturing practices, making sure that what’s labeled on the product is actually in the product at the right potency, making sure there’s no contamination, and so on. There is a lot of science that really goes into a probiotic product, and I don’t think that we communicate that strongly enough, often enough, and eloquently enough.”
Best practice in clinical trials
IPA has produced best practice guidelines for both labeling and manufacturing, and these could be joined by guidance on best practice in clinical trials, said Dr Terhaar.
Such a guidance would be very timely, she said, given the recent negative press around probiotics.
“If you drill down into most of the studies [that were the subject of those negative headlines], there are gaps in the study design or the research questions asked.
“I think it’s a tell-tale mark of the lack of a best practices guide of some sort for clinical trials for studying the efficacy of probiotics,” she said.
Dr Terhaar also called for more collaboration between different stakeholders in the probiotics field. “If you take for example genomic databases, your data is only as good as the reference database that you have, so there should be sharing of these databases.
“From the IPA perspective, we’re looking at trying to stimulate collaboration and bring partners together, trying to understand where the gaps are, and navigate the politics that are going alongside it. We need to work together to protect the integrity of probiotics.”
IPA is also working towards preparing its membership for the taxonomic changes to the Lactobacillus genus. This includes commercially important strains such as casei, paracasei, plantarum, salivarius, reuteri, and rhamnosus, but these will no longer be lactobacillus.
“The genus Lactobacillus has grown too big,” said Dr Terhaar. “There are over 200 different organisms within that classification and that’s just too large for the scientific community. Essentially, what will happen is they will be reclassified and renamed. This is going to have seismic impact on the industry because these are species within the genus with commercial importance.”
IPA will work with its members to ensure the companies activate internally to ensure these changes are integrated within the quality checks with labeling and packaging, she said, and to educate external stakeholders to make sure they are aware that these changes are happening.
“This has implications on multiple levels, from IP and patents down to the GRAS list,” she said.