NCT03386643

Effect of Bifidobacterium Animalis Subsp. Lactis HN019 on Oral Lichen Planus

Completed Phase 2 Last updated 27 March 2020

What this trial tests

Phase 2 trial testing Bifidobacterium animalis subsp. lactis HN019 in Oral Lichen Planus in 22 participants. Completed in 6 December 2019.

Timeline

6 November 2017

Primary endpoint
5 April 2018

6 December 2019

Quick facts

Lead sponsor	University of Sao Paulo
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	22
Start date	6 November 2017
Primary completion	5 April 2018
Estimated completion	6 December 2019
Sites	1 location across Brazil

Drugs / interventions tested

• Bifidobacterium animalis subsp. lactis HN019 — full drug profile →
• Clobetasol propionate 0.05%

Conditions studied

• Oral Lichen Planus — all drugs for Oral Lichen Planus →

Sponsor

University of Sao Paulo

Who can join

18 and older, any sex, with Oral Lichen Planus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interventions for treating oral lichen planus: corticosteroid therapies.
   Lodi G, Manfredi M, Mercadante V, Murphy R, et al · · 2020 · cited 89× · PMID 32108333 · DOI 10.1002/14651858.cd001168.pub3