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.

Conditions

• Oral Lichen Planus

Interventions

DRUG

Bifidobacterium animalis subsp. lactis HN019

The selected patients will receive capsules to be diluted in 15 ml of water containing 6 x 109 CFUs of Bifidobacterium subsp. lactis HN019 for mouthwash twice a day for 4 weeks.

DRUG

Clobetasol propionate 0.05%

The selected patients will receive capsules to be diluted in 15ml of water containing clobetasol propionate 0.05% for mouthwash twice a day for 4 weeks.

Sponsors & Collaborators

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Michel Reis Messora, DDS, PhD · University of São Paulo, Ribeirão Preto, SP, Brazil.

• Sergio L. Souza Salvador, DDS, PhD · University of São Paulo, Ribeirão Preto, SP, Brazil.

• Átila V. Vitor Nobre, DDS · University of São Paulo, Ribeirão Preto, SP, Brazil.

• Cristhiam de J. Hernández Martínez, DDS · University of São Paulo, Ribeirão Preto, SP, Brazil.

• Kleber Tanaka Suzuki, DDS · University of São Paulo, Ribeirão Preto, SP, Brazil.

• Marina C. Gabriel Del Arco · University of São Paulo, Ribeirão Preto, SP, Brazil.

• Lara Maria A Innocentini, DDS,PhD · University of São Paulo, Ribeirão Preto, SP, Brazil.

• Gilberto A Silva, MS · University of São Paulo, Ribeirão Preto, SP, Brazil.

• Ellen E Monteiro, Student · University of São Paulo, Ribeirão Preto, SP, Brazil

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-06

Primary Completion

2018-04-05

Completion

2019-12-06

Countries

• Brazil

Study Locations