Otsuka Pharmaceutical Co., Ltd. (Otsuka), through its Nutraceuticals Research Institute (Otsu research site), conducted a specified clinical study¹ in collaboration with the Institute of Science Tokyo and others. The study demonstrated that consumption of a food product containing the lactic acid bacterium Lactiplantibacillus pentosus ONRICb0240 (lactic acid bacterium ONRICb0240)² significantly reduced Bleeding On Probing rate (BOP%)³, an indicator of gingivitis, as well as the Gingival Index (GI)⁴, which reflects gingival swelling and redness. The results of this study were published in the Journal of Periodontology, an international academic journal, on April 20.

■Research Background

Periodontal disease is a chronic inflammatory condition that is estimated to affect approximately 3.5 billion people worldwide. If left untreated, it can lead not only to tooth loss but has also been reported to have adverse effects on systemic health. Gingivitis, a precursor stage of periodontal disease, is considered a "reversible" condition that can return to a healthy state with appropriate care; however, for many people, maintaining gingival health through daily tooth brushing alone is not easy.

Our company began research into "gut immunity" in 2000 and has conducted research for more than 20 years on the immunostimulatory properties of the lactic acid bacterium ONRICb0240.⁵˒⁶˒⁷ As part of this effort, based on the concept that "the link from intestinal microbiota to oral microbiota connects oral care to overall health," research in the oral health field was initiated in 2017. To date, results have suggested that lactic acid bacterium ONRICb0240 promotes the secretion of immune substances (IgA) in saliva and may enhance mucosal immunity.⁸ Accordingly, a specified clinical study was conducted with a food product containing lactic acid bacterium ONRICb0240 in adults with mild gingival inflammation.⁹

■Study Overview

Participants: 116 adults with mild gingival inflammation (e.g., gingival bleeding)

Study Design: A randomized, double-blind, parallel-group, placebo-controlled trial.
No tooth-brushing instruction or other oral hygiene guidance was provided. While maintaining their usual daily lifestyles, study participants consumed either a food containing lactic acid bacterium ONRICb0240 or a placebo food not containing the bacterium. The products were taken twice daily (morning and afternoon), two units per dose, for a total of four units per day over a six-week period.

■Summary of Results

1.　For the Bleeding On Probing rate (BOP%), an indicator of inflammation, a statistically significant　reduction was observed in the lactic acid bacterium ONRICb0240 group compared with the placebo group. In the ONRICb0240 group, the BOP% decreased from 17.6% at baseline to 12.3% after six weeks, corresponding to a relative reduction of approximately 30%.

2.　For the Gingival Index (GI), an assessment by dentists of gingival swelling and redness,　no significant difference was observed between the two groups. However, after six weeks, only the lactic acid bacterium ONRICb0240 group showed a statistically significant improvement compared with baseline.

In our nutraceutical business, we leverage the expertise accumulated through our pharmaceutical business to promote the maintenance and improvement of human health and the overall well-being of society. We are committed to research and development of innovative, scientifically substantiated products that contribute to solving health and social challenges. Currently, research and development related to beverages and foods are conducted at the Nutraceuticals Research Institute (Saga research site and Otsu research site) as well as at the Advanced Science Research Institute.

Based on the corporate philosophy of 'Otsuka-people creating new products for better health worldwide,' Otsuka Pharmaceutical continues to contribute to the health and well-being of people around the world.

• 1.A clinical study conducted under the Clinical Research Act, which requires a high level of ethical standards and transparency. Review and approval by a nationally certified ethics review board (Certified Review Board: CRB) are mandatory.
• 2.Lactic acid bacteria isolated by Tokyo University of Agriculture from miang, a fermented tea leaf product native to northern Thailand.
• 3.BOP (Bleeding On Probing): A phenomenon in which bleeding is observed when a periodontal probe is used during periodontal pocket examination.
• 4.GI (Gingival Index): An index used to evaluate the severity of gingival inflammation (redness, swelling, and bleeding) on a scale from 0 to 3.
• 5.Okada S, et al. Flora of lactic acid bacteria in Miang produced in northern Thailand. Journal of General and Applied Microbiology. 1986; 32: 57-65.
• 6.Kishi K, et al. Lactobacillus plantarum ONRICb0240 increases salivary IgA levels in healthy adults. Journal of the Japanese Society for Lactic Acid Bacteria. 2006; 17: 132-137. (in Japanese)
• 7.Kotani Y, et al. Oral intake of Lactobacillus pentosus strain b240 accelerates salivary immunoglobulin A secretion in the elderly. Immunity & Aging. 2010; 7: 11.
• 8.Shimizu S, et al. Effects of continuous intake of lactic acid bacterium B240 on salivary components and properties in healthy adults: A randomized, double-blind, placebo-controlled trial. Pharmacology and Therapeutics. 2018; 46: 1571-1577. (in Japanese)
• 9.A total of 116 adults who were not using medications known to affect gingival inflammation.

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide. For further information, please visit www.otsuka.co.jp/en/