Biome Australia has initiated its first human clinical trial for the proprietary probiotic strain Lactobacillus plantarum BMB18, aiming to validate its benefits for digestive and mood-related symptoms.
- First human trial for proprietary probiotic BMB18 registered and ethics approval submitted
- Randomised, double-blind, placebo-controlled study with 240 participants planned for February 2026
- Trial targets digestive symptoms and mood or sleep disturbances
- In vitro studies showed BMB18 modulates immune response and supports gut integrity
- Partnership with La Trobe University strengthens scientific rigor and product innovation
A Milestone in Probiotic Research
Biome Australia Limited (ASX – BIO) has taken a significant step forward by launching its first human clinical trial for its proprietary probiotic strain, Lactobacillus plantarum BMB18. This trial, registered with the Australia New Zealand Clinical Trials Registry and pending ethics approval, is set to commence in February 2026. It represents a critical phase in Biome's strategy to translate promising laboratory findings into clinically validated health solutions.
Trial Design and Objectives
The study will recruit 240 participants experiencing digestive symptoms such as bloating and discomfort, as well as those with occasional sleep or mood disturbances. Employing a rigorous randomised, double-blind, placebo-controlled design, the trial will test two active dosage levels of BMB18 against a placebo. This approach aims to generate robust data that can support multiple product development pathways within Biome's portfolio.
Scientific Foundations and Strategic Importance
Prior in vitro research demonstrated that BMB18 effectively modulates immune responses, reduces inflammation and oxidative stress, and helps maintain intestinal barrier integrity. These findings laid the groundwork for clinical exploration, aligning with Biome’s Vision 27 strategic plan focused on proprietary strain development and commercialisation. A successful trial outcome would not only validate BMB18’s health benefits but also reinforce Biome’s competitive edge through intellectual property ownership.
Partnership and Market Potential
Biome’s collaboration with La Trobe University, a continuation of a fruitful research partnership, ensures the trial meets high scientific standards. The gut health category remains Biome’s largest sales volume segment, and clinical validation of BMB18 is expected to drive significant growth and innovation in this space. With increasing consumer awareness of the gut-brain connection, products addressing digestive and mood-related symptoms are well positioned for market expansion.
Looking Ahead
With a modest budget of approximately $140,000 managed within existing R&D funds, this 12-month trial is a cost-effective investment in Biome’s future. Managing Director Blair Norfolk highlighted the trial’s potential to differentiate Biome in a competitive market and to support new product launches that could substantially boost sales.
Bottom Line?
Biome’s clinical trial for BMB18 could redefine its market position and accelerate growth in gut health innovation.
Questions in the middle?
- Will the clinical trial confirm the in vitro benefits of BMB18 in human subjects?
- How quickly can Biome translate positive trial results into new commercial products?
- What competitive responses might emerge from other probiotic developers?