Food safety assessment and 28-day toxicity study of the synbiotic medical food consortium SBD121.

The human gut microbiome plays a crucial role in immune function. The synbiotic consortium or Defined Microbial Assemblage™ (DMA™) Medical Food product, SBD121, consisting of probiotic microbes and prebiotic fibers was designed for the clinical dietary management of rheumatoid arthritis. A 28-day repeated administration study was performed to evaluate the oral toxicity of SBD121 in male and female rats (age/weight at study start: 60 days/156-264 g) administered levels of 0, 4.96 x 1010, 2.48 x 1011, or 4.96 x 1011 colony forming units (CFU)/kg-bw. No treatment related changes were observed in ophthalmological effects, mortality, morbidity, general health and clinical observations, urinalysis, hematology, serum chemistry, absolute or relative organ weights, gross necropsy, or histopathology. A significant decrease in body weight was reported in females in the low and high-concentration groups, which corresponded in part with a significant decrease in food consumption. Results of the functional observation battery indicated front grip strength was significantly greater in the high-concentration males compared to the controls; however, this effect was not considered adverse. Based on these findings, the administration of the Medical Food SBD121 to male and female rats has a no-observable adverse effect level (NOAEL) at the highest level tested of 4.96 x 1011 CFU/kg-bw.

Food safety assessment and toxicity study of the synbiotic consortium SBD111.

The human gut microbiome plays a crucial role in skeletal homeostasis. The synbiotic consortium or Defined Microbial Assemblage™ (DMA™) food product, SBD111, consisting of probiotic microbes and prebiotic fibers was designed to promote bone health based on its capacity to produce short chain fatty acids (SCFA), the presence of genes for vitamin K2 production, and its ability to degrade plant fibers. A 28-day repeated administration study was performed to evaluate the oral toxicity of SBD111 in female rats (age/weight at study start: 5-7 weeks/120-180 g) administered levels of 0, 2.0 x 1010, 9.8 x 1010, or 2.0 x 1011 colony forming units (CFU)/kg-bw. No mortality or morbidity occurred during the study. There were no significant differences in body weights, hematology, serum chemistry, coagulation, organ weights, or food consumption in the test groups compared to the controls. Liver weight to body weight ratios were signficantly decreased at 9.8 x 1010 CFU/kg-bw when compared to controls. No treatment related changes in motor activity, sensory stimuli, or grip strength were observed. Based on these findings, SBD111 administered to female rats has a no-observable adverse effect level (NOAEL) at the highest level tested of 2.0 x 1011 CFU/kg-bw.

Evaluation of dermal corrosion and irritation by Cytoreg in rabbits.

Cytoreg is an experimental therapeutic platform consisting of an aqueous solution of six acids (hydrofluoric, hydrochloric, sulfuric, phosphoric, citric, and oxalic) with oncolytic, antiviral, immune modulatory and antibacterial activities. Cytoreg may be formulated for topical, oral, and parenteral administration. In the present study, a skin corrosion/irritation screen was conducted on three albino rabbits for the Cytoreg topical formulation at three dilutions; one animal each received a dilution of 100 %, 4 %, or 2 % in physiological saline solution. Three intact skin test sites per animal/concentration were evaluated. Each test site was treated with 0.5 mL of the appropriate test substance solution. Site one was dosed for 3 min, then observed. Dose site two was wrapped for 1 h, then both first and second test sites were observed. Dose site three was wrapped for 4 h. One hour after unwrapping the third site, all three test sites were observed for skin irritation and/or corrosion, and again at 24, 48 and 72 h after final unwrap. Based on the 4 -h dose scores through 72 h, the primary irritation index (PII) for Cytoreg is 0.00 at 2 % and 4 %, with a descriptive rating of non-irritating, and 0.25 PII with slightly irritating rating at 100 %.