Oral Lichen PlanusCABRIONCT03052179
The Clinical and Biological Effects Of The Use Of Probiotic VSL#3 In Patients With Oral Lichen Planus
A study testing Poly-biotic in people with Oral Lichen Planus, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Poly-biotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Aug 2017to 11 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College of London Hospital
London, WC1E 6BT
About this study
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
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.
Read the 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.
A randomized, double blinded, placebo-controlled trial study on individuals with OLP.
Patients with painful ulcerative biopsy-confirmed OLP attending the Oral Medicine clinics of the UCLH ( University college of London hospital) Eastman Hospital and meeting the inclusion criteria of the study will be given information about the trial and invited to participate.
30 individuals who consent will be recruited and randomised in two groups: group A (15 participants) will receive the VSL#3 and group B (15 participants) will receive a placebo. A centralised computer-generated randomization list provided by an independent third party will be used to conceal allocation of patients to the treatments. The list will be sent to the drug manufacturer who will label the VSL#3 or placebo with relevant study participant code, which will come in the same identical plain-packages to ensure blinding (neither the participants nor the investigator will be aware of the sachets content). The study statistician will also be blinded to the allocation. Patients will be allowed to use best standard therapy during the study.
To demonstrate the research hypotheses, Investigators will record oral painful symptoms, disease activity, and quality of life in participants before, at 15 and 30 days from treatment start, and 30 days (day 60) after the last VSL#3 supplement intake.
60 days + 15 days 21 months Single-site 30 participants
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.
- I. R. H. Kramer, R. B. Lucas, J. J. Pindborg, and L. H. Sobin, "Definition of leukoplakia and related lesions: an aid to studies on oral precancer," Oral Surgery Oral Medicine and Oral Pathology, vol. 46, no. 4, pp. 518-539, 1978
Exclusion Criteria
- The use of systemic antibiotics, retinoid, corticosteroids or immunosuppressant within four weeks prior to enrolment in the study.
- Pregnancy* or receiving IVF treatment.
- Individuals with known history of systemic disorders affecting the immune system (e.g., connective tissue disorders, cancer, etc.)
- Active cancer or cancer in remission undergoing maintenance with chemotherapy or immunomodulatory agents.
- Evidence of oral epithelial dysplasia or malignancy on previous biopsy.
- Evidence of negative pregnancy test at screening / randomization visit (strip urine test) in women of child-bearing age in which the possibility of being pregnant cannot be otherwise excluded.
- Conditions
- Oral Lichen Planus
- Being tested
- Poly-biotic
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-bioticDietary supplement
Also called VSL#3 5015919450087
Before-after treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Poly-biotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (2)
ESS
Escudier's scoring system to measure disease activity based on size and number of lesion
Measured: 30 days
COMDQ
Validated questioner for chronic oral mucosal disease
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start24 Aug 2017
- Primary completion11 Sep 2018
- Study completion11 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, randomized, placebo-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew M Smith, Dr, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052179
- Sponsor's protocol ID
- 16/0622
- Acronym
- CABRIO
- Status last verified
- Mar 2020
- First submitted
- 9 Feb 2017
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data will be kept anynomous. This data only accessible by the party mention in the protocols
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03052179
- Acronym / sponsor ID
- CABRIO / 16/0622
- Conditions
- Oral Lichen Planus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 11 Sep 2018 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
A randomized, double blinded, placebo-controlled trial study on individuals with OLP.
Patients with painful ulcerative biopsy-confirmed OLP attending the Oral Medicine clinics of the UCLH ( University college of London hospital) Eastman Hospital and meeting the inclusion criteria of the study will be given information about the trial and invited to participate.
30 individuals who consent will be recruited and randomised in two groups: group A (15 participants) will receive the VSL#3 and group B (15 participants) will receive a placebo. A centralised computer-generated randomization list provided by an independent third party will be used to conceal allocation of patients to the treatments. The list will be sent to the drug manufacturer who will label the VSL#3 or placebo with relevant study participant code, which will come in the same identical plain-packages to ensure blinding (neither the participants nor the investigator will be aware of the sachets content). The study statistician will also be blinded to the allocation. Patients will be allowed to use best standard therapy during the study.
To demonstrate the research hypotheses, Investigators will record oral painful symptoms, disease activity, and quality of life in participants before, at 15 and 30 days from treatment start, and 30 days (day 60) after the last VSL#3 supplement intake.
60 days + 15 days 21 months Single-site 30 participants
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.
- I. R. H. Kramer, R. B. Lucas, J. J. Pindborg, and L. H. Sobin, "Definition of leukoplakia and related lesions: an aid to studies on oral precancer," Oral Surgery Oral Medicine and Oral Pathology, vol. 46, no. 4, pp. 518-539, 1978
Exclusion Criteria
- The use of systemic antibiotics, retinoid, corticosteroids or immunosuppressant within four weeks prior to enrolment in the study.
- Pregnancy* or receiving IVF treatment.
- Individuals with known history of systemic disorders affecting the immune system (e.g., connective tissue disorders, cancer, etc.)
- Active cancer or cancer in remission undergoing maintenance with chemotherapy or immunomodulatory agents.
- Evidence of oral epithelial dysplasia or malignancy on previous biopsy.
- Evidence of negative pregnancy test at screening / randomization visit (strip urine test) in women of child-bearing age in which the possibility of being pregnant cannot be otherwise excluded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blind, randomized, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| VSL#3 | Active comparator | Dietary Supplement: Poly-bioticVSL#3 poly-biotic 450 billion in sachet orally, two sachets in the morning and two sahcets in the evening for 30 days |
| Placebo | Placebo comparator | Dietary Supplement: Poly-bioticMaltose in sachet orally, two sachets in the morning and two sahcets in the evening for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Poly-bioticAlso: VSL#3 5015919450087Before-after treatment | Dietary supplement | Placebo, VSL#3 |
Primary outcome
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.
2 secondary outcomes
ESS
Time frame: 30 days
COMDQ
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Individual participant dataSharing planned: No. the data will be kept anynomous. This data only accessible by the party mention in the protocols
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew M Smith, Dr principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Poly-biotic in people with Oral Lichen Planus, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain - Numeric Rating Scale (NRS) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.