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

NCT03052179 | Completed DMC

• 1 other identifier: 16/0622
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (1)

• pain - Numeric Rating Scale (NRS)

  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.

  30 days

Secondary Outcomes (2)

• ESS

  30 days

• COMDQ

  30 days

Other Outcomes (2)

• Metagenomic changing in saliva

  30 days

• Cytokine serum level

  30 days

Study Arms (2)

VSL#3

ACTIVE COMPARATOR

VSL#3 poly-biotic 450 billion in sachet orally, two sachets in the morning and two sahcets in the evening for 30 days

Dietary Supplement: Poly-biotic

Placebo

PLACEBO COMPARATOR

Maltose in sachet orally, two sachets in the morning and two sahcets in the evening for 30 days

Dietary Supplement: Poly-biotic

Interventions

Poly-biotic DIETARY_SUPPLEMENT

Before-after treatment

Also known as: VSL#3 5015919450087

Placebo; VSL#3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College of London Hospital

London, WC1E 6BT, United Kingdom

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andrew M Smith, Dr

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind, randomized, placebo-controlled

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 14, 2017
• Study Start: August 24, 2017
• Primary Completion: September 11, 2018
• Study Completion: September 11, 2018
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)