Effect of Bifidobacterium Animalis Subsp. Lactis HN019 on Oral Lichen Planus
Status:
Completed
Trial end date:
2019-12-06
Target enrollment:
Participant gender:
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.