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International Journal of Toxicology
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Safety Assessment of ProBiora3, a Probiotic Mouthwash: Subchronic Toxicity Study in Rats

Jeffrey D. Hillman
Emily McDonell
Charles H. Hillman
Robert T. Zahradnik
Madhu G. Soni

From the Oragenics, Alachua, Florida, (JDH, EM, RTZ); University of Illinois, Kinesiology and Community Health Department, Champaign, Illinois, (CHH); and Soni & Associates, Vero Beach, Florida, (MGS).

Correspondence: Madhu G. Soni, PhD, Soni & Associates Inc, 749 46th Square, Vero Beach, FL 32968; e-mail: sonim{at}bellsouth.net.

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, ProBiora3). The blend is administered to rats orally once daily (5 days per week) at doses of 0, 106, or 109 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 ProBiora3 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 109 colony-forming units per strain per kilogram of body weight per day, the highest dose used.

Key Words: probiotic • mouthwash • dental • chronic toxicity • histopathology • viridans streptococci

International Journal of Toxicology, Vol. 28, No. 5, 357-367 (2009)
DOI: 10.1177/1091581809340705
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