Probiotics, as defined by the World Health Organization, are live microorganisms that, when consumed in sufficient quantities, provide health benefits to the host. Although some countries have approved specific probiotic species for use in food, safety concerns may still arise with individual strains. Lacticaseibacillus paracasei subsp. paracasei NTU 101 (NTU 101), isolated from the gut of healthy infants, has demonstrated various probiotic effects and shown safety in a prior 28-day animal feeding study. To further verify its safety and mitigate potential risks, we performed a comprehensive genotypic and phenotypic safety evaluation in accordance with the European Food Safety Authority guidelines for safety assessment through whole genome sequencing and related literature. In this research, minimum inhibitory concentration testing identified NTU 101’s resistance to chloramphenicol; however, subsequent gene analysis confirmed no associated risk of resistance. Assessments of safety, including biogenic amine content, hemolytic activity, mucin degradation, and D-lactic acid production, indicated a low level of risk. Additionally, a repeated-dose 90-day oral toxicity study in Sprague-Dawley rats revealed no toxicity at a dose of 2000 mg/kg body weight, further supporting the strain’s safety for consumption. Based on these comprehensive analyses, NTU 101 is considered safe for regular consumption as a health supplement.

Gut microbiota dysbiosis is increasingly being recognized as a major contributor to host metabolic imbalance, immune dysfunction, and neurophysiological disorders. Probiotics are known to modulate intestinal metabolism and exert systemic effects through the gut–brain axis. Herein, we evaluated the safety and probiotic potential of Pediococcus acidilactici SWP-CGPA01 (SWP-CGPA01) under antibiotic-induced microbiota dysbiosis. Genomic and phenotypic analyses verified its safety profile, supporting its suitability for use in food and nutritional applications. In a mouse model of antibiotic-induced dysbiosis, SWP-CGPA01 supplementation alleviated diarrhea and restored hippocampal brain-derived neurotrophic factor expression. These findings demonstrate that SWP-CGPA01 is a safe and functionally active probiotic with the potential to maintain gastrointestinal and neurotrophic homeostasis under gut microbiota dysbiosis.

Probiotics, as defined by the World Health Organization, are live microorganisms that, when consumed in sufficient quantities, provide health benefits to the host. Although some countries have approved specific probiotic species for use in food, safety concerns may still arise with individual strains. Lacticaseibacillus paracasei subsp. paracasei NTU 101 (NTU 101), isolated from the gut of healthy infants, has demonstrated various probiotic effects and shown safety in prior 28-day animal feeding study. To further verify its safety and mitigate potential risks, we performed a comprehensive genotypic and phenotypic safety evaluation in accordance with European Food Safety Authority guidelines for safety assessment through whole genome sequencing and related literature. In this research, minimum inhibitory concentration testing identified NTU 101's resistance to chloramphenicol; however, subsequent gene analysis confirmed no associated risk of resistance. Assessments of safety, including biogenic amine content, hemolytic activity, mucin degradation, and D-lactic acid production, indicated a low level of risk. Additionally, a repeated dose 90-day oral toxicity study in Sprague-Dawley rats revealed no toxicity at a dose of 2000 mg/kg body weight, further supporting the strain's safety for consumption. Based on these comprehensive analyses, NTU 101 is considered safe for regular consumption as a health supplement.