• Ethics approval submitted and study registered with ANZCTR
• Randomised, double-blind, placebo-controlled trial recruiting 240 participants
• Targeting patients with digestive, sleep or mood disturbances
• Positive outcome expected to support growth in gut health sales

Biome Australia Limited (ASX: BIO) has announced the submission of ethics approval and registration of the first human clinical trial on its proprietary probiotic strain, Lactobacillus plantarum BMB18 (BMB18). This marks a significant milestone in the company's research, intellectual property (IP) and product development strategy. The randomised, double-blind, placebo-controlled trial will recruit 240 participants across two active dosage levels and placebo to investigate the efficacy of BMB18 in patients experiencing digestive symptoms (e.g. bloating, discomfort) and/or occasional sleep or mood disturbances. The trial is scheduled to commence in February 2026 and will be conducted in partnership with La Trobe University. The study follows successful completion of in vitro research demonstrating BMB18's ability to effectively modulate immune responses and inflammation, reduce oxidative stress, and maintain intestinal barrier integrity. Successful clinical validation of BMB18 is expected to strengthen Biome's competitive position, support new product development, provide additional protection from competition, drive innovation in next-generation probiotic formulations, and expand addressable market opportunities in gastrointestinal health. The trial represents a critical phase in the clinical validation of this proprietary strain and aligns with Biome's Vision 27 strategic plan focused on identification, characterisation and commercialisation of proprietary probiotic strains.

Successful clinical validation of BMB18 is expected to drive significant growth in Biome's gut health category, which represents the company's largest sales volume.