Oral Lichen PlanusNCT01743690
The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus
A study testing Probiotic lactobacilli reuteri, Nystatin and fluocinolone in people with Oral Lichen Planus and Candida Infection, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim is to investigate the effect of probiotic bacteria on symptoms and clinical manifestations in patients with oral lichen planus (OLP). The hypothesis is that probiotic bacteria can favor an oral environment that reduces the risk of symptomatic candidal and bacterial infection in OLP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Lichen Planus, Candida Infection
- What is being tested?
- Probiotic lactobacilli reuteri, Nystatin and fluocinolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Dec 2015
- 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
- Symptomatic Oral Lichen Planus
Who cannot join
- Antibiotic treatment within 3 months
Trial locations and contacts
1 site in 1 country.
About this study
The aim is to investigate the effect of probiotic bacteria on symptoms and clinical manifestations in patients with oral lichen planus (OLP).
The hypothesis is that probiotic bacteria can favor an oral environment that reduces the risk of symptomatic candidal and bacterial infection in OLP.
Read more
The negative influence of improper oral hygiene on OLP is established and overgrowth of Candida is a common problem. Nystatin is the only topical antifungal that does not interact with other drugs and to which the majority of the candida species are susceptible. Symptomatic treatment with fluocinolone is initiated in patients without candidal infection. Probiotic bacteria can affect the microbial homeostasis by reducing the overgrowth of pathogens e.g. candida. Different probiotic species have been shown to produce antifungal substances and reduce the growth of candida albicans in vitro. The probiotic strain Lactobacillus rhamnosus has been found to reduce the salivary count of yeasts among elderly in a randomized clinical study.
The study is planned as a blinded, randomized controlled study with four parallel arms. 120 OLP patients with symptoms form the mucous membranes are included in the study and will receive nystatin or fluocinolone treatment depending on positive or negative diagnosis of candidosis. In addition, they will be assigned to either the probiotic (A) or the placebo group (B) by randomization. The groups will be encouraged to take three tablets per day (morning, noon and evening)for eight weeks. The lozenges containseither two strains of the probiotic bacterium L. reuteri (A) or placebo (B). Cytosmears, saliva sample, and saline mouth wash will be taken at baseline, after the treatment period and at follow-up visits at 8, 16, 24 weeks and 1 year. Salivary counts of the probiotic strains, the clinical manifestations and symptoms associated to OLP will be recorded.
- Conditions
- Oral Lichen Planus, Candida Infection
- Being tested
- Probiotic lactobacilli reuteri, Nystatin, fluocinolone
- Keywords
- Probiotic, Candida, Oral Lichen Planus
- Medical subject headings
- Lichen Planus, Oral, Candidiasis, Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic lactobacilli reuteriBiological
Also called L. reuteri (DSM 17938 og ATCC PTA 5289) two times a day
NystatinDrug
fluocinoloneDrug
| Study group | Role | What they receive |
|---|---|---|
| fluocinolone, placebo | Active comparator | fluocinolone, placebo Receives: Drug: fluocinolone |
| fluocinolone, probiotic | Experimental | fluocinolone, Probiotic lactobacilli reuteri Receives: Biological: Probiotic lactobacilli reuteri; Drug: fluocinolone |
| Nystatin, placebo | Active comparator | Nystatin, placebo Receives: Drug: Nystatin |
| nystatin, probiotic | Experimental | nystatin, Probiotic lactobacilli reuteri Receives: Biological: Probiotic lactobacilli reuteri; Drug: Nystatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of candida infections
Measured: after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2015
- Study completionDec 2015
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 of CopenhagenThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Kirstine Keller, University of Copenhagen
- Investigators
- Mette K Keller, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743690
- Sponsor's protocol ID
- H-4-2011-143
- Status last verified
- Dec 2015
- First submitted
- 28 Nov 2012
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT01743690
- Acronym / sponsor ID
- H-4-2011-143
- Conditions
- Oral Lichen Planus, Candida Infection
- Keywords
- Probiotic, Candida, Oral Lichen Planus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Dec 2012 (estimated)
- 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.
The aim is to investigate the effect of probiotic bacteria on symptoms and clinical manifestations in patients with oral lichen planus (OLP).
The hypothesis is that probiotic bacteria can favor an oral environment that reduces the risk of symptomatic candidal and bacterial infection in OLP.
The negative influence of improper oral hygiene on OLP is established and overgrowth of Candida is a common problem. Nystatin is the only topical antifungal that does not interact with other drugs and to which the majority of the candida species are susceptible. Symptomatic treatment with fluocinolone is initiated in patients without candidal infection. Probiotic bacteria can affect the microbial homeostasis by reducing the overgrowth of pathogens e.g. candida. Different probiotic species have been shown to produce antifungal substances and reduce the growth of candida albicans in vitro. The probiotic strain Lactobacillus rhamnosus has been found to reduce the salivary count of yeasts among elderly in a randomized clinical study.
The study is planned as a blinded, randomized controlled study with four parallel arms. 120 OLP patients with symptoms form the mucous membranes are included in the study and will receive nystatin or fluocinolone treatment depending on positive or negative diagnosis of candidosis. In addition, they will be assigned to either the probiotic (A) or the placebo group (B) by randomization. The groups will be encouraged to take three tablets per day (morning, noon and evening)for eight weeks. The lozenges containseither two strains of the probiotic bacterium L. reuteri (A) or placebo (B). Cytosmears, saliva sample, and saline mouth wash will be taken at baseline, after the treatment period and at follow-up visits at 8, 16, 24 weeks and 1 year. Salivary counts of the probiotic strains, the clinical manifestations and symptoms associated to OLP will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| fluocinolone, placebo | Active comparator | Drug: fluocinolonefluocinolone, placebo |
| fluocinolone, probiotic | Experimental | Biological: Probiotic lactobacilli reuteri, Drug: fluocinolonefluocinolone, Probiotic lactobacilli reuteri |
| Nystatin, placebo | Active comparator | Drug: NystatinNystatin, placebo |
| nystatin, probiotic | Experimental | Biological: Probiotic lactobacilli reuteri, Drug: Nystatinnystatin, Probiotic lactobacilli reuteri |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic Oral Lichen Planus
Key exclusion criteria (1 listed)
- Antibiotic treatment within 3 months
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 |
|---|---|---|
| Probiotic lactobacilli reuteriAlso: L. reuteri (DSM 17938 og ATCC PTA 5289) two times a day | Biological | fluocinolone, probiotic, nystatin, probiotic |
| Nystatin | Drug | Nystatin, placebo, nystatin, probiotic |
| fluocinolone | Drug | fluocinolone, placebo, fluocinolone, probiotic |
Primary outcome
recurrence of candida infections
Time frame: after 1 year
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 11 Dec 2015.
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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.
Mette K Keller, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic lactobacilli reuteri, Nystatin and fluocinolone in people with Oral Lichen Planus and Candida Infection, run by University of Copenhagen at 1 site in Denmark.
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 1 inclusion and 1 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 11 Dec 2015. 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 Denmark. 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. 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?
recurrence of candida infections (time frame: after 1 year). 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 11 Dec 2015.