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

• DOI: 10.1111/odi.14014
• Publication Date: 2021-08-31T22:34:50Z
• Authors: Erni Marlina; Richard N. Goodman; Valeria Mercadante; Martina Shephard; Roddy McMillan; Tim Hodgson; Rachel Leeson; Stephen Porter; Julie A. Barber; Stefano Fedele; Andrew M. Smith
• Keywords: Probiotics; VSL#3; Pain; Pilot Projects; wr_100; 3. Good health; qu_145.5; 03 medical and health sciences; oral lichen planus; 0302 clinical medicine; Quality of Life; the clinical and biological effects of the use of probiotic in patients with oral lichen planus; Humans; wu_100; probiotic; Lichen Planus, Oral

AbstractObjectiveTo preliminary evaluate the clinical effects of probiotics in individuals with symptomatic oral lichen planus and the possible mechanisms of action.Subjects and MethodsA 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.ResultsThe 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.ConclusionsThe 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.