The Clinical and Biological Effects Of The Use Of Probiotic VSL#3 In Patients With Oral Lichen Planus : a Proof-of-concept Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University College, London
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- pain - Numeric Rating Scale (NRS)
Study Overview
Brief Summary
Oral Lichen Planus (OLP) is an inflammatory disease of mucosal and skin with unknown etiology. The prevalence rate in England is reported to be between 1-2.4%. OLP contributed to around 40% of all visits or 1,200 appointments in 2014 at the Eastman Dental Hospital. Pain, discomfort, long-standing use of medications, lesion recurrence and adverse side effects of therapy are commonly associated with OLP, eventually leading to a significant reduction in a patient quality of life. In addition, there is also 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 (IBD), with no adverse effect a part than bloating, reported. Additionally, a preliminary report shown that probiotics 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.
Investigator 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 a single site research site (Eastman Dental Hospital (EDH)). Either the active VSL#3 or the placebo, provided by Ferring Pharmaceuticals Limited, will be consume twice a day over a 30 days period. Questionnaires that will determine pain levels, disease activity and quality of life will be completed 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 before therapy begin, at 30 days of therapy, and 30 days after the last supplement intake. The levels of pro-inflammatory cytokines and the oral microbiota will be investigated using these samples. A blinded clinician will assess the clinical effects between groups of active VSL #3 and placebo and the results will analyze by statistician.
Detailed Description
Primary objective:
• To investigate the effects of 30 days use of supplement therapy of probiotic VSL#3 on painful symptoms of OLP at the end of the therapy (30-days endpoint) and 30 days after the last dose (60-days endpoint).
Secondary objective:
- To investigate the effects of 30 days use of supplement therapy of probiotic VSL#3 on OLP disease activity.
- To investigate the effect of 30 days use of supplement therapy of probiotic VSL#3 on quality of life.
- To investigate acceptability of the intervention and potential adverse effects. and for the mechanistic study, whether :
- The use of VSL#3 is associated with metagenomics changes in saliva.
- The use of VSL#3 is associated with changes in the serum expression profile of pro-inflammatory cytokines.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Masking Description
Either participant or the investigator will be blinded. The key of randomisation will be held by the third statistician party, and the company which supply and labeled the product study.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Biopsy-proven diagnosis of OLP as per WHO histological criteria* with no evidence of epithelial dysplasia or malignancy.
- •Presence of painful oral symptoms associated to OLP, with minimum severity of pain being 3 or more, on a 0-10 numeric pain rating scale at screening and confirmed at recruitment/start of the intervention.
- •Age >18 years and willing to participate into the study.
- •Receiving no therapy or receiving best standard topical therapy (typically topical corticosteroids or immunosuppressant) with the exclusion of systemic corticosteroids or systemic immunosuppressant
Exclusion Criteria
- •Use of systemic antibiotics, retinoid, corticosteroids or immunosuppressant.
- •Pregnancy or receiving IVF treatment.
- •Individuals with systemic disorders affecting the immune system (e.g., HIV, connective tissue disorders, cancer, etc.)
- •Evidence of oral dysplasia or malignancy on previous biopsy. -
Outcomes
Primary Outcomes
pain - Numeric Rating Scale (NRS)
Time Frame: 30 days
is a 10 point scale for participant self-reporting pain. Participant will asked to point out the scale from 0 = no pain and 10 = worse pain can imagine.
Secondary Outcomes
- ESS(30 days)
- COMDQ(30 days)