Biome Australia (ASX:BIO) has cleared the final regulatory hurdle to begin a landmark human clinical trial for its proprietary probiotic strain, Lactobacillus plantarum BMB18.
The La Trobe University Human Research Ethics Committee recently granted formal approval for the study, which is scheduled to commence in February.
The randomised, double-blind, placebo-controlled trial will recruit 240 participants to evaluate the strain's efficacy in managing digestive issues, sleep disturbances, and mood instability.
By utilising two active dosage levels, Biome aims to generate robust data to support the commercialisation of its wholly-owned intellectual property across its Activated Probiotics and Activated Therapeutics product lines.
At the time of reporting, Biome Australia's share price was $0.48.