title: Safety assessment of ProBiora3, a probiotic mouthwash: subchronic toxicity study in rats.
abstract: Streptococcus viridans are commensal bacteria that constitute a significant portion of the resident oral microflora. The objective of the present study is to investigate adverse effects, if any, of a blend of 3 natural strains, Streptococcus uberis KJ2, Streptococcus oralis KJ3, and Streptococcus rattus JH145 (probiotic mouthwash, ProBiora(3)). The blend is administered to rats orally once daily (5 days per week) at doses of 0, 10(6), or 10(9) colony-forming units of each strain for 14 weeks. No treatment-related adverse effects are observed in the physiological parameters during the study or in the evaluation of blood and tissue samples taken from the animals at the end. Results of an in vitro antibiotic susceptibility study demonstrate that all 3 ProBiora(3) strains are susceptible to commonly used therapeutic antibiotics. The results of these investigations reveal that the no-observed-adverse-effect level of the probiotic mouthwash is 2.16 x 10(9) colony-forming units per strain per kilogram of body weight per day, the highest dose used.
authors.affiliation: Oragenics, Alachua, Florida, USA.
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Hillman
authors.forename: Emily
authors.initials: E
authors.lastname: McDonell
authors.forename: Charles H
authors.initials: CH
authors.lastname: Hillman
authors.forename: Robert T
authors.initials: RT
authors.lastname: Zahradnik
authors.forename: Madhu G
authors.initials: MG
authors.lastname: Soni
mesh_terms: D000284:Administration, Oral; D000818:Animals; D000900:Anti-Bacterial Agents / Q000494:pharmacology; D001835:Body Weight / Q000187:drug effects; D015169:Colony Count, Microbial; D003257:Consumer Product Safety; D004326:Drinking / Q000187:drug effects; D004435:Eating / Q000187:drug effects; D005260:Female; D008297:Male; D008826:Microbial Sensitivity Tests; D009061:Mouth Mucosa / Q000382:microbiology; D009067:Mouthwashes / Q000633:toxicity*; D009929:Organ Size / Q000187:drug effects; D019936:Probiotics / Q000633:toxicity*; D051381:Rats; D017207:Rats, Sprague-Dawley; D036401:Toxicity Tests, Chronic / Q000379:methods*; D034363:Viridans Streptococci / Q000187:drug effects / Q000254:growth & development
chemical_list: D000900:Anti-Bacterial Agents; D009067:Mouthwashes