CABRIO proof of concept study V1.1 020217
Research type
Research Study
Full title
The Clinical and biological effects of the use of probiotic VSL#3 in patients with oral lichen planus: a preliminary proof-of-concept study
IRAS ID
220177
Contact name
AM Smith
Contact email
Sponsor organisation
University College of London
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
174235, Award Number; Z6364106/2017/02/21 clinical research, UCL Data Protection Registration
Duration of Study in the UK
1 years, 8 months, 31 days
Research summary
Summary of Research
Oral Lichen Planus (OLP) is an inflammatory disease of mucosal and skin with unknown aetiology. The prevalence rate in England is reported to be between 1-2.4%. OLP contributed to around 40% of all visits (1,200 appointments) in 2014 at the Eastman Dental Hospital (EDH). Pain, discomfort, long standing use of medications, lesion recurrence and adverse side effects of therapy are commonly associated with OLP, leading to a significant reduction in a patient quality of life. There is also an increased risk of developing oral cancer in patients with OLP. The current gold standard treatment for OLP is corticosteroid, which can result in adverse side-effects including increased risk of infections and skin cancer, reduced systemic immune system, and hepatotoxicity with long-term usage.
Alternatively, a probiotic food supplement, VSL#3, has shown evidence of been able to induce and maintain remission in inflammatory Bowel Disease, with no adverse effects apart from bloating. A preliminary report has shown that probiotic treatment in Behcet’s disease and Recurrent Aphthous Stomatitis (RAS) lesion resulted in reducing the number of oral ulcerations and subjective relief of oral discomfort.
We have designed a clinical trial with 30 participants allocated to one of two interventions, VSL#3 or placebo. Individuals with biopsy-confirmed OLP who experience painful symptoms will be recruited from EDH. The active VSL#3 or placebo, will be consume twice a day over a 30 days period. Pain levels, disease activity and quality of life will be determined before the study begins, on days 15, 30 and 30 days after the last supplement intake. In addition saliva and blood samples will be taken and levels of pro-inflammatory cytokines and the oral microbiota will be investigated. A blinded clinician will assess the clinical effects between groups of active VSL #3 and placebo and the results will analyse by statistician.Summary of Results
The study was designed to evaluate the clinical effects of probiotics in individuals with symptomatic oral lichen planus and the possible mechanisms of action.
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.
The probiotic VSL#3 was found to be safe and well tolerated. We observed no statistically significant change in pain, disease activity, quality of life or oral microbial composition with respect to placebo.
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.REC name
London - Queen Square Research Ethics Committee
REC reference
17/LO/0475
Date of REC Opinion
11 Apr 2017
REC opinion
Further Information Favourable Opinion