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Abstract A safety evaluation was performed of Symbiota®, which is made by a proprietary anaerobic fermentation process of soybean with multistrains of probiotics and a yeast. The battery of genotoxicity studies showed that Symbiota® has no genotoxic effects. Safety and tolerability were further assessed by acute or repeated dose 28‐ and 90‐day rodent studies, and no alterations in clinical observations, ophthalmological examination, blood chemistry, urinalysis, or hematology were observed between the control group and the different dosing groups (1.5, 5, and 15 mL/kg/day). There were no adverse effects on specific tissues or organs in terms of weight and histopathology. Importantly, the Symbiota® treatment did not perturb hormones and other endocrine‐related endpoints. Of note, the No‐Observed‐Adverse‐Effect‐Level was determined to be 15 mL/kg/day in rats. Moreover, a randomized, double‐blind, placebo‐controlled clinical trial was recently conducted with healthy volunteers who consumed 8 mL/day of placebo or Symbiota® for 8 weeks. Only mild adverse events were reported in both groups, and the blood chemistry and blood cell profiles were also similar between the two groups. In summary, this study concluded that the oral consumption of Symbiota® at 8 mL/day by the general population does not pose any human health concerns.

Merkel cell carcinoma (MCC) is a rare neuroendocrine tumour typically affecting the skin of fair-skinned or immunosuppressed, though it can affect the oral mucosa. We report the fourth documented case of MCC of the tongue in an 87-year-old male presenting with a cervical mass causing odynophagia and dysphagia. The diagnosis was confirmed through core biopsy histopathology and immunohistochemical analysis positive for CK20, synaptophysin and chromogranin. In situ hybridisation for human papillomavirus types 16 and 18 was negative, excluding HPV-driven oropharyngeal squamous cell carcinoma. Non-operative management with intensity-modulated radiotherapy and avelumab immunotherapy was commenced, inducing a complete metabolic response of the primary lesion. Thirty-three months after diagnosis, 31 months after completing initial radiotherapy, the patient is clinically well with no residual disease. Despite a dearth of documented cases, our protocol suggests that novel techniques for cutaneous MCC management with immunotherapy combined with our improved knowledge of MCC radiobiology may be successfully applied to managing locally advanced oral MCC, potentially shifting the treatment paradigm from upfront surgery toward targeted oncotherapy.