First Human trial on Proprietary BMB18 Strain

The first human clinical trial on proprietary probiotic strain Lactobacillus plantarum BMB1 with the Australian and New Zealand Clinical Trials registry was registered and submitted with ethics approval by Biome Australia on December 15, 2025.

Initiatives:

• Biome Australia is partnering with La Trobe University to commence this human trial in February 2026, to make a spectacular and groundbreaking step in the company's research, intellectual properties, and strategies for product development.
• Biome planned to conduct the 12-month study for around $140,000 and manage it under the company's existing research and development budget.
• Biome is expected to represent excellent value for the critical validation of BMB 18’s clinical advantages and advancements of the company’s proprietary strain technology.
• The study conducted by Biome following the successful completion of in vitro research demonstrates the BMB 18’s strong capability of modulating immune responses and inflammation, reducing oxidative stress, and maintaining the intestinal barrier integrity.
• The partnership between Biome Australia and La Trobe University is ensuring the trial meets with rigorous scientific standards and reinforces Biome’s commitment to evidence-based product development.

Motive Behind the Trail

240 participants, with robust data for multiple product development options, will be recruited in a randomized, double-blind, and placebo-controlled trial. This first human trial is planned to investigate the efficacy of BMB 18 in patients who experience digestive symptoms like discomfort and bloating, and occasional sleep or mood disturbances. Researchers are set to examine BMB 18’s impact on digestive function, mood, sleep, and quality of life in this trial.

Biome’s largest volume category remains as gut disorders and targeted gut health, with growth potential as the continuous expansion of consumer awareness regarding the connections of gut health. Biome is expecting clinical validation of BMB 18 for supporting substantial sales growth within already available products with enable innovations of novel products.

Vision 27 Strategic Plan Behind Biome’s First Human Trail on BMB 18:

The BMB 18 clinical trial aligned with Biome’s vision 27 strategic plan, especially the supply chain development of the pillar focused on identifying, characterizing, and commercializing proprietary probiotic strains.

The BMB 18’s successful clinical validation is expected to enhance Biome’s competitive position and support novel product development within the Activated probiotics and Activated Therapeutics ranges.

This trial is projected to continue Biome’s successful research collaboration and partnership with La Trobe University, following the Biome Lift Probiotic clinical trial partnership, which produced several publications to support the applications of the product for patients with mental health concerns.

Blair Norfolk Statement on Registration of the First Human Clinical Trial on BMB 18:

Blair Norfolk, managing director and founder, has stated that the registration of the first human clinical trial on BMB 18 will represent years of dedication by the Biome team to research and development.

According to Blair Norfolk, millions of Australians are facing the problem of gastrointestinal symptoms and the development of clinical validated solutions for these common health issues, and concerns are central to Biome’s mission in enhancing health results by using evidence-based microbiome science.