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A proof of concept pilot trial of probiotics in symptomatic oral lichen planus (CABRIO)

Marlina, Erni, Goodman, Richard, Mercadante, Valeria, Shephard, Martina, McMillan, Roddy, Hodgson, Tim, Leeson, Rachel, Porter, Stephen, Barber, Julie A., Fedele, Stefano and Smith, Andrew M. (2021) 'A proof of concept pilot trial of probiotics in symptomatic oral lichen planus (CABRIO)'. Oral Diseases. (In Press)

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Abstract

Objective
To preliminary evaluate the clinical effects of probiotics in individuals with symptomatic oral lichen planus and the possible mechanisms of action.

Subjects and Methods
A group of 30 individuals with symptomatic oral lichen planus were recruited in a randomised double-blind parallel group controlled (1:1) proof-of-concept pilot trial of probiotic VSL#3 vs placebo. Efficacy outcomes included changes in pain numeric rating scale, oral disease severity score and the chronic oral mucosal disease questionnaire. Adverse effects, home diary and withdrawals were assessed as feasibility outcomes. Mechanistic outcomes included changes in salivary and serum levels of CXCL10 and IFN-γ and in oral microbial composition.

Results
The probiotic VSL#3 was safe and well tolerated. We observed no statistically significant change in pain, disease activity, quality of life, serum/salivary CXCL10 or oral microbial composition with respect to placebo. Salivary IFN-γ levels demonstrate a trend for a reduced level in the active group (p = 0.082) after 30 days of probiotic consumption.

Conclusions
The present proof-of-concept study provides some weak not convincing indication of biological and clinical effects of probiotic VSL#3 in individuals with painful oral lichen planus. Further research in this field is needed, with the current study providing useful information to the design of future clinical trials.

Item Type: Article
Subjects: QU Biochemistry > Vitamins > QU 145.5 Nutritive values of food
WR Dermatology > WR 100 General works
WU Dentistry. Oral Surgery > WU 100 General works
Faculty: Department: Biological Sciences > Department of Tropical Disease Biology
Digital Object Identifer (DOI): https://doi.org/10.1111/odi.14014
Depositing User: Cathy Waldron
Date Deposited: 10 Sep 2021 08:19
Last Modified: 10 Sep 2021 08:19
URI: https://archive.lstmed.ac.uk/id/eprint/18859

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