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The Clinical and Biological Effects Of The Use Of Probiotic VSL#3 In Patients With Oral Lichen Planus

NCT03052179 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-03-27

No results posted yet for this study

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.

Conditions

  • Oral Lichen Planus

Interventions

DIETARY_SUPPLEMENT

Poly-biotic

Before-after treatment

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Andrew M Smith, Dr · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-24
Primary Completion
2018-09-11
Completion
2018-09-11

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03052179 on ClinicalTrials.gov