PS128 is a patented probiotic strain and has been researched in terms of efficacy and safety for diverse applications.
HUMAN CLINICAL STUDIES
PS128 Psychobiotic Safety Test Results
The National Yang-Ming University Institute of Food Safety and Health Risk Assessment was commissioned to carry out the following safety tests
PS128 does not require FDA approval (since it is not designated as a food additive.) To certify its safety, self-affirmed GRAS (generally recognized as safe) status was obtained. Before being granted this designation, qualified experts must agree that scientific data and information about the substance establishes the safety of its intended use. Lactobacillus plantarum PS128 received self-affirmed GRAS status in 2020.
The strain PS128 was identified as Lactobacillus plantarum . L. plantarum is generally recognized as safe for consumption by major regulatory bodies.
PS128 is not genotoxic nor resistant to antibiotics . It meets EFSA food safety standards.
In both human and animal trials, PS128 has not demonstrated any side effects .
 Liu, W. H., Yang, C. H., Lin, C. T., Li, S. W., Cheng, W. S., Jiang, Y. P., Wu, C. C., Chang, C. H., & Tsai, Y. C. (2015). Genome architecture of Lactobacillus plantarum PS128, a probiotic strain with potential immunomodulatory activity. Gut pathogens, 7, 22.
 Liao, P. L., Wu, C. C., Chen, T. Y., Tsai, Y. C., Peng, W. S., Yang, D. J., & Kang, J. J. (2019). Toxicity Studies of Lactobacillus plantarum PS128TM Isolated from Spontaneously Fermented Mustard Greens. Foods (Basel, Switzerland), 8(12), 668.
 Liu, W. H., Chuang, H. L., Huang, Y. T., Wu, C. C., Chou, G. T., Wang, S., & Tsai, Y. C. (2016). Alteration of behavior and monoamine levels attributable to Lactobacillus plantarum PS128 in germ-free mice. Behavioural brain research, 298(Pt B), 202–209.
 Liu, Y. W., Liong, M. T., Chung, Y. E., Huang, H. Y., Peng, W. S., Cheng, Y. F., Lin, Y. S., Wu, Y. Y., & Tsai, Y. C. (2019). Effects of Lactobacillus plantarum PS128 on Children with Autism Spectrum Disorder in Taiwan: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients, 11(4), 820.