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

NCT03386643 | Completed Phase 2 DMC

• 1 other identifier: CAAE: 63003716.2.0000.5419
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oral lichen planus; Probiotics; Immunomodulation.

Outcome Measures

Primary Outcomes (1)

• Change in symptoms intensity measure

  Self reported symptoms at baseline, 15 and 30 days after therapy through an visual analogue scale (VAS). It consists of a subjective scale scoring the symptoms from 0 to 10 (0 = no symptoms and 10 = as bad as can be).

  4 weeks

Secondary Outcomes (3)

• Histopathological analysis

  Before (baseline) and one month after intensive topical therapy

• Immunohistochemical analysis

  After 4 weeks of intensive therapy.

• Venous blood collection

  Before (baseline) and after 4 weeks of topical therapy

Study Arms (2)

Bifidobacterium animalis subsp. lactis

EXPERIMENTAL

Intervention: Bifidobacterium animalis subsp. lactis HN019

Drug: Bifidobacterium animalis subsp. lactis HN019

Clobetasol propionate 0.05%

ACTIVE COMPARATOR

Intervention: Clobetasol propionate 0.05%

Drug: Clobetasol propionate 0.05%

Interventions

Bifidobacterium animalis subsp. lactis HN019 DRUG

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.

Also known as: Probiotic

Bifidobacterium animalis subsp. lactis

Clobetasol propionate 0.05% DRUG

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.

Also known as: Topical corticosteroid

Clobetasol propionate 0.05%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years old, both genres, who consent to participate of the study;
• Presence of symptomatic reticular lesion and/or white-gray papules. In afro-descendent individuals, reticular lesions may be associated with hyperpigmented lesions;
• Additional clinical features such as ulcerative, erythematous, plaque and bullous lesions will be accepted in the presence of bilateral and symmetrical reticular lesions.
• Presence of subepithelial infiltrate predominantly lymphocytic, in band and confined to the subepithelial area.
• Liquefaction degeneration of the basal cells layer.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of Dentistry of Ribeirão Preto, University of São Paulo

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Related Publications (5)

• 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.

  PMID: 28499235 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.

  PMID: 28756997 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.

  PMID: 27829754 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.

  PMID: 28662142 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.

  PMID: 28678976 BACKGROUND

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Probiotics; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Michel Reis Messora, DDS, PhD

  University of São Paulo, Ribeirão Preto, SP, Brazil.

  STUDY CHAIR

• Sergio L. Souza Salvador, DDS, PhD

  University of São Paulo, Ribeirão Preto, SP, Brazil.

  STUDY CHAIR

• Átila V. Vitor Nobre, DDS

  University of São Paulo, Ribeirão Preto, SP, Brazil.

  STUDY CHAIR

• Cristhiam de J. Hernández Martínez, DDS

  University of São Paulo, Ribeirão Preto, SP, Brazil.

  STUDY CHAIR

• Kleber Tanaka Suzuki, DDS

  University of São Paulo, Ribeirão Preto, SP, Brazil.

  STUDY CHAIR

• Marina C. Gabriel Del Arco

  University of São Paulo, Ribeirão Preto, SP, Brazil.

  STUDY CHAIR

• Lara Maria A Innocentini, DDS,PhD

  University of São Paulo, Ribeirão Preto, SP, Brazil.

  STUDY CHAIR

• Gilberto A Silva, MS

  University of São Paulo, Ribeirão Preto, SP, Brazil.

  STUDY CHAIR

• Ellen E Monteiro, Student

  University of São Paulo, Ribeirão Preto, SP, Brazil

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both patients and investigators who will assess the outcomes have no knowledge of the interventions assigned to individual participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teacher of Oral Diagnosis-Department of Stomatology, Public Oral Health and Forensic Dentistry

Model Details: Symptomatic patients presenting OLP will be randomly assigned to either topical Bifidobacterium animalis subsp lactis HN019 or clobetasol propionate 0.05%, and they will receive capsules to be diluted in 15 ml of water containing 6 x 109 CFUs of Bifidobacterium subsp. lactis HN019 (experimental group) or 0.05% clobetasol propionate (control group) for mouth washing, twice a day for 4 weeks.

Study Record Dates

• First Submitted: December 2, 2017
• First Posted: December 29, 2017
• Study Start: November 6, 2017
• Primary Completion: April 5, 2018
• Study Completion: December 6, 2019
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)