Probiotics are widely commercialized as key ingredients in functional foods and dietary supplements; however, ensuring their safety is critical for consumers. In particular, safety must be carefully evaluated at the strain level, as both efficacy and potential risks can vary between strains. In this study, the safety of a novel probiotic strain, Lactiplantibacillus plantarum LMT1–48, was comprehensively evaluated using phenotypic, genomic, and toxicity studies. Minimum Inhibitory Concentration (MIC) values of all tested antibiotics were lower than the cut-off values of the European Food Safety Authority (EFSA) guidelines. Lactiplantibacillus plantarum LMT1–48 did not exhibit hemolytic activity nor cytotoxicity. Production of harmful metabolites is also evaluated. The whole genome sequencing did not reveal any antibiotic resistance- or virulence-related genes. Neither single- nor repeated-dose oral toxicity studies have shown any treatment-related toxicological changes at any dose level. Overall, our results suggest that Lactiplantibacillus plantarum LMT1–48 is a safe probiotic strain for human consumption.
Background Calcium channel blocker (CCB) overdose carries substantial mortality without advanced organ support. Ingestion of a fixed-dose antihypertensive combination with a non-steroidal anti-inflammatory drug (NSAID) is an uncommon polypharmacy toxidrome. The role of intravenous lipid emulsion (ILE) and methylene blue in refractory cases remains poorly defined. Case report A 64-year-old man (135 kg) ingested approximately 300 mg amlodipine, 300 mg perindopril, 75 mg indapamide and 15,000 mg naproxen with ethanol. Despite apparent stability on arrival he deteriorated to 77/47 mmHg, pH 7.20 and lactate 10.5 mmol/L. Seven hours of escalating treatment — noradrenaline (peak 58 mcg/min), vasopressin, calcium and high-dose insulin euglycaemic therapy (HIET) — failed to restore haemodynamic targets. Intralipid 20% was given (total approximately 8.9 mL/kg), followed 35 min later by methylene blue 140 mg (1.0 mg/kg). Lactate fell from 10.5 to 6.1 mmol/L over the subsequent 55 min with the noradrenaline dose unchanged. All vasopressors were stopped within 14 h. HIET was accompanied by concurrent glucose, potassium and phosphate nadirs (1.7, 1.7 and 0.27 mmol/L). KDIGO stage 2 acute kidney injury (peak creatinine 303 µmol/L) required no renal replacement therapy and resolved completely (creatinine 81 µmol/L at 3.5 months). The patient was discharged on day 9. Conclusion Sequential ILE and methylene blue were temporally associated with rapid metabolic recovery in refractory circulatory shock following polypharmacy antihypertensive overdose. Individual contributions cannot be determined from a single case, and a delayed effect of concurrent HIET cannot be excluded. These agents may represent rescue options when conventional therapy is insufficient.
A putative probiotic bacterial organism, Faecalibacterium taiwanense, (FTAI) was evaluated in a series of different genotoxicity studies and repeat-dose oral gavage studies to evaluate the safety of FTAI for addition to food. The studies were consistent with Organisation for Economic Co-operation and Development (OECD) protocols. Irradiated FTAI was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay and not clastogenic when tested in an in vitro mammalian chromosomal aberration test. The F. taiwanense strain was not genotoxic in a mouse in vivo mammalian cell micronucleus assay when administered at up to 6.98 × 10 11 AFU/kg body weight/day. The test substance was provided to rats via gavage at target doses of 500, 1000, and 2000 mg/kg body weight/day (equivalent to 1.94 × 10 11 , 2.81 × 10 11 , and 9.53 × 10 11 active fluorescent units [AFU]/kg body weight/day, respectively) in a range–finding rat study lasting 14 days. Test substance intake did not cause mortality or treatment-related adverse effects in any endpoint. In a 90-day study, bacterial translocation from the intestinal tract to the liver, mesenteric lymph nodes, and blood was observed, but based on polymerase chain reaction analysis, none of the colonies were FTAI. The no-observed-adverse-effect level was stated at the highest dose tested: 2000 mg/kg body weight/day (approximately 1.32 × 10 12 AFU/kg body weight/day). These results show that this F. taiwanense strain was not genotoxic, did not cause toxicity when ingested as analyzed in the stated studies.
