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Trial record 1 of 1 for:    Probiotic VSL#3 lichen
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The Clinical and Biological Effects Of The Use Of Probiotic VSL#3 In Patients With Oral Lichen Planus (CABRIO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03052179
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
University College, London

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.


Condition or disease Intervention/treatment Phase
Oral Lichen Planus Dietary Supplement: Poly-biotic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind, randomized, placebo-controlled
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.
Primary Purpose: Supportive Care
Official Title: The Clinical and Biological Effects Of The Use Of Probiotic VSL#3 In Patients With Oral Lichen Planus : a Proof-of-concept Study
Actual Study Start Date : August 24, 2017
Actual Primary Completion Date : September 11, 2018
Actual Study Completion Date : September 11, 2018

Arm Intervention/treatment
Active Comparator: VSL#3
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
Before-after treatment
Other Name: VSL#3 5015919450087

Placebo Comparator: Placebo
Maltose in sachet orally, two sachets in the morning and two sahcets in the evening for 30 days
Dietary Supplement: Poly-biotic
Before-after treatment
Other Name: VSL#3 5015919450087




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. ESS [ Time Frame: 30 days ]
    Escudier's scoring system to measure disease activity based on size and number of lesion

  2. COMDQ [ Time Frame: 30 days ]
    Validated questioner for chronic oral mucosal disease


Other Outcome Measures:
  1. Metagenomic changing in saliva [ Time Frame: 30 days ]
    To observed changing of bacterial composition before and after treatment

  2. Cytokine serum level [ Time Frame: 30 days ]
    To observed changing in serum level cytokine before and after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Biopsy-proven diagnosis of OLP as per WHO histological criteria* with no evidence of epithelial dysplasia or malignancy.
  2. 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.
  3. Age >18 years and willing to participate into the study.
  4. 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:

  1. Use of systemic antibiotics, retinoid, corticosteroids or immunosuppressant.
  2. Pregnancy or receiving IVF treatment.
  3. Individuals with systemic disorders affecting the immune system (e.g., HIV, connective tissue disorders, cancer, etc.)
  4. Evidence of oral dysplasia or malignancy on previous biopsy. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052179


Locations
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United Kingdom
University College of London Hospital
London, United Kingdom, WC1E 6BT
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Andrew M Smith, Dr University College, London
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03052179    
Other Study ID Numbers: 16/0622
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: the data will be kept anynomous. This data only accessible by the party mention in the protocols

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases