Effect of Bifidobacterium Animalis Subsp. Lactis HN019 on Oral Lichen Planus
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|ClinicalTrials.gov Identifier: NCT03386643|
Recruitment Status : Active, not recruiting
First Posted : December 29, 2017
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Oral Lichen Planus||Drug: Bifidobacterium animalis subsp. lactis HN019 Drug: Clobetasol propionate 0.05%||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Both patients and investigators who will assess the outcomes have no knowledge of the interventions assigned to individual participants.|
|Official Title:||Effect of the Probiotic Bifidobacterium Animalis Subsp. Lactis HN019 on Clinical, Histopathological and Immunophenotypic Features of Oral Lichen Planus|
|Actual Study Start Date :||November 6, 2017|
|Actual Primary Completion Date :||April 5, 2018|
|Estimated Study Completion Date :||June 6, 2019|
Experimental: Bifidobacterium animalis subsp. lactis
Bifidobacterium animalis subsp. lactis HN019
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.
Other Name: Probiotic
Active Comparator: Clobetasol propionate 0.05%
Clobetasol propionate 0.05%
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.
Other Name: Topical corticosteroid
- Change in symptoms intensity measure [ Time Frame: 4 weeks ]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).
- Histopathological analysis [ Time Frame: Before (baseline) and one month after intensive topical therapy ]Biopsies will be collected at the baseline stage or at the time of the diagnosis of OLP (optional), consisting of a 5mm x 5mm fragment or a 4mm punch of reticular lesions. The second biopsy will be optional, with patient consent, close to the area of the first biopsy for comparative purposes. The histological findings will be determined quantitatively and qualitatively regarding the presence of epithelial hyperplasia, degeneration by liquefaction of the basal cells layer, lymphocytic infiltrate in the subepithelial connective tissue, and apoptotic cells. Photographs will be used at 400x and quantification using the Image J. program.
- Immunohistochemical analysis [ Time Frame: After 4 weeks of intensive therapy. ]The population of inflammatory cells will be characterized by analysis of oral mucosa samples, with emphasis on the T cell line (CD3, CD4, CD8, CD25, CD103, perforin, granzyme B and Foxp3), B cells (CD20 / CD20), dendritic cells (CD123 and CD303), submucosal dendritic cells (CD209 and factor XIIIa), Langerhans cells (CD1a and CD207), endothelial activity (e-selectin and CD31), mast cells ), macrophages (CD68 and CD163), myeloid dendritic cells (S100 and CD11c), cell proliferation markers (Ki-67, MCM-2, MCM-5, cyclin D1) and extracellular matrix (laminin-5). For immunohistochemical reactions, histological sections of 3μm thickness will be performed, which will be placed on slides coated with organosilane (Sigma-Aldrich, St Louis, MO, USA).
- Venous blood collection [ Time Frame: Before (baseline) and after 4 weeks of topical therapy ]10 ml of venous blood to evaluate the probiotic systemic effect, by means of the research of pro-inflammatory, anti-inflammatory and regulatory cytokines.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386643
|School of Dentistry of Ribeirão Preto, University of São Paulo|
|Ribeirão Preto, São Paulo, Brazil, 14040-904|
|Study Chair:||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|