Effect of Bifidobacterium Animalis Subsp. Lactis HN019 on Oral Lichen Planus
Summary
Lichen planus is a chronic inflammatory mucocutaneous disease, which often results in oral manifestations, receiving the name of oral lichen planus (OLP). Its frequency varies from 0,1 to 4% of the general population, with a higher incidence in women, around the 4th and 5th decades of life. Although the pathogenesis of OLP is related to a immune-cellular response, mainly mediated by T lymphocytes, its cause remains unknown. Considering its chronic nature, control of OLP aims to reduce symptoms and improve function, and agents with anti-inflammatory action, especially topical corticosteroids result in some degree of success in most patients, depending on the clinical presentation. However, some cases are resistant to the use of corticosteroids, thus justifying the search for new therapeutic options. The immunomodulation proved to be one of the main functions of probiotic bacteria, and recent studies have shown effect of probiotics on decreasing the expression of inflammatory markers, which enables the study of this therapy as an alternative to the control of OLP. Thus, this project aims to evaluate the effects of therapy with Bifidobacterium animalis subsp. lactis HN019 comparing with clobetasol propionate 0.05% in symptomatic patients with OLP referred for diagnosis and treatment of School of Dentistry of Ribeirão Preto - University of São Paulo (USP). The impact of the topical therapy (probiotic or corticosteroid) on the clinical, histopathological and immunopathological features will be evaluated. This project was previously submitted and approved by the Institutional Review Board of the School of Dentistry of Ribeirão Preto/USP, and all patients must give informed consent to participate in this study.
Timeline
- Start
- 2017-11-06
- Primary completion
- 2018-04-05
- Completion
- 2019-12-06
Publications
- Background Han X, Zhang J, Tan Y, Zhou G. Probiotics: A non-conventional therapy for oral lichen planus. Arch Oral Biol. 2017 Sep;81:90-96. doi: 10.1016/j.archoralbio.2017.04.026. Epub 2017 Apr 26.
- Background Garcia-Pola MJ, Gonzalez-Alvarez L, Garcia-Martin JM. Treatment of oral lichen planus. Systematic review and therapeutic guide. Med Clin (Barc). 2017 Oct 23;149(8):351-362. doi: 10.1016/j.medcli.2017.06.024. Epub 2017 Jul 28. English, Spanish.
- Background Sivaraman S, Santham K, Nelson A, Laliytha B, Azhalvel P, Deepak JH. A randomized triple-blind clinical trial to compare the effectiveness of topical triamcinolone acetonate (0.1%), clobetasol propionate (0.05%), and tacrolimus orabase (0.03%) in the management of oral lichen planus. J Pharm Bioallied Sci. 2016 Oct;8(Suppl 1):S86-S89. doi: 10.4103/0975-7406.191976.
- Background Ricoldi MST, Furlaneto FAC, Oliveira LFF, Teixeira GC, Pischiotini JP, Moreira ALG, Ervolino E, de Oliveira MN, Bogsan CSB, Salvador SL, Messora MR. Effects of the probiotic Bifidobacterium animalis subsp. lactis on the non-surgical treatment of periodontitis. A histomorphometric, microtomographic and immunohistochemical study in rats. PLoS One. 2017 Jun 29;12(6):e0179946. doi: 10.1371/journal.pone.0179946. eCollection 2017.
- Background Gerhard D, Sousa FJDSS, Andraus RAC, Pardo PE, Nai GA, Neto HB, Messora MR, Maia LP. Probiotic therapy reduces inflammation and improves intestinal morphology in rats with induced oral mucositis. Braz Oral Res. 2017 Jul 3;31:e71. doi: 10.1590/1807-3107BOR-2017.vol31.0071.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VSL#3 | Other / unclassified | 6e+09 cells | Other |
| Comparator | clobetasol propionate | Small molecule | 0.05 % | Other |