Biome Australia (ASX: BIO) has submitted ethics approval and registered its first human clinical trial on proprietary probiotic strain Lactobacillus plantarum BMB18 with the Australia New Zealand Clinical Trials Registry.
The company plans to commence the trial in February 2026 in partnership with La Trobe University, marking a significant milestone in its research, intellectual property, and product development strategy.
Biome will conduct the 12-month study for approximately $140,000 and manage it within the company's existing research and development budget, representing excellent value for this critical validation of BMB18's clinical benefits and advancement of Biome's proprietary strain technology.
The study follows successful completion of in vitro research demonstrating BMB18's strong ability to modulate immune responses and inflammation, reduce oxidative stress, and maintain intestinal barrier integrity.
Digestive and Mood Symptoms
The randomised, double-blind, placebo-controlled trial will recruit 240 participants, providing robust data for multiple product development opportunities.
The trial will investigate BMB18's efficacy in patients experiencing digestive symptoms such as bloating and discomfort, as well as occasional sleep or mood disturbances.
Researchers will also examine BMB18's impact on digestive function, mood, sleep, and quality of life.
Gut disorders and targeted gut health remain Biome's largest volume category, with significant growth potential as consumer awareness of the gut-health connection continues to expand.
Biome expects clinical validation of BMB18 to support substantial sales growth across existing products while enabling new product innovation.
Vision 27 Strategy Alignment
The BMB18 clinical trial aligns with Biome's Vision 27 strategic plan—specifically, the supply chain development pillar focused on identification, characterisation, and commercialisation of proprietary probiotic strains.
Successful clinical validation of BMB18 will strengthen Biome's competitive position and support new product development across the Activated Probiotics and Activated Therapeutics ranges.
The trial continues Biome's successful research partnership with La Trobe University, following the Biome Lift Probiotic clinical trial collaboration that produced several publications supporting the product's application for patients with mental health concerns.
This partnership ensures the trial meets rigorous scientific standards and reinforces Biome's commitment to evidence-based product development.
Managing director and founder Blair Norfolk said the registration of the first human clinical trial on BMB18 represents years of dedicated research and development work by the Biome team.
"Gastrointestinal symptoms affect millions of Australians, and developing clinically validated solutions for these common health concerns is central to our mission of improving health outcomes through evidence-based microbiome science," he said.
