Novonesis touts pioneering probiotic Clepius L. Plantarum’s approval for gut and brain health claims

15 Mar 2024 --- Novonesis recently achieved a significant milestone with Health Canada’s approval of two health claims for its probiotic strain, Clepius L. plantarum. According to the company, the approval marks a pioneering moment in the realm of probiotics and positions the strain as the first probiotic in Canada recognized for offering stress relief, alongside its benefits for gastrointestinal health.

The approval underscores the strain’s ability to mitigate perceived stress in individuals experiencing moderate stress levels and enhance gastrointestinal functions, which includes promoting a favorable gut environment and supporting digestion.

“The strain was chosen due to certain properties shown in preclinical experiments,” Elisabet Nordström, PhD, head of global scientific advisory, human health at Novonesis, tells Nutrition Insight. “These include gastrointestinal (GI) persistence, maintenance of intestinal barrier function and anti-pathogenic, anti-inflammatory and bile salt hydrolase activity.”

“The areas of gut health and gut-brain axis are at the core of our scientific activities within human health biosolutions.”

Evidence-based claims
According to Novonesis, the Health Canada approval stems from a detailed submission by the company, which incorporated solid clinical evidence and research demonstrating the strain’s health advantages.

Critical to this approval were studies indicating Clepius L. plantarum’s role in significantly improving GI symptoms, such as abdominal pain and bloating, when compared to a placebo. Additionally, the strain showed promise in delivering substantial stress relief through daily supplementation, showcasing broad-spectrum health benefits.Dr. Nordström reveals that Clepius L. plantarum showed significant health effects at both the lower and higher doses.

“We used a randomized double-blinded, placebo-controlled, multi-center and dose-ranging study with strong results on a range of different investigated parameters,” explains Nordström. “This was a dose-ranging study and strong effects were shown both for the low and higher dose of one billion colony-forming units (CFU) and 10 billion CFU of live probiotic bacteria, respectively.”

“This data allows for science-based product differentiation to address different needs of the market.”

The future of health
Novonesis highlights that the regulatory nod not only spotlights its dedication to pushing the frontiers of probiotic science but also marks a significant step forward in the probiotics market by allowing manufacturers to leverage these scientifically-backed health claims to distinguish their products. 

Additionally, the company says the approval also reflects the growing consumer demand for natural, effective solutions to manage health issues like stress and gastrointestinal discomfort. 

Novonesis also states that Clepius L. plantarum is expected to become a vital component in probiotic supplements and functional foods in Canada and beyond. Moreover, it appeals to customers and consumers looking for products that can influence the gut axes.

“The role of the gut-brain axis spans across a range of health indications, including stress, sleep, anxiety and more,” Nordström concludes. “Research and innovation are at the heart of Novonesis and we are committed to drive innovation and make new discoveries that enable us to bring new products to market for better and healthier lives.”

By William Bradford Nichols