The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus
Primary Purpose
Oral Lichen Planus, Candida Infection
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Probiotic lactobacilli reuteri
Nystatin
fluocinolone
Sponsored by
About this trial
This is an interventional prevention trial for Oral Lichen Planus focused on measuring Probiotic, Candida, Oral Lichen Planus
Eligibility Criteria
Inclusion Criteria:
- Symptomatic Oral Lichen Planus
Exclusion Criteria:
- Antibiotic treatment within 3 months
Sites / Locations
- University of Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Active Comparator
Experimental
Arm Label
fluocinolone, placebo
fluocinolone, probiotic
Nystatin, placebo
nystatin, probiotic
Arm Description
fluocinolone, placebo
fluocinolone, Probiotic lactobacilli reuteri
Nystatin, placebo
nystatin, Probiotic lactobacilli reuteri
Outcomes
Primary Outcome Measures
recurrence of candida infections
Secondary Outcome Measures
Full Information
NCT ID
NCT01743690
First Posted
November 28, 2012
Last Updated
December 10, 2015
Sponsor
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT01743690
Brief Title
The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus
Official Title
The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus, Candida Infection
Keywords
Probiotic, Candida, Oral Lichen Planus
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fluocinolone, placebo
Arm Type
Active Comparator
Arm Description
fluocinolone, placebo
Arm Title
fluocinolone, probiotic
Arm Type
Experimental
Arm Description
fluocinolone, Probiotic lactobacilli reuteri
Arm Title
Nystatin, placebo
Arm Type
Active Comparator
Arm Description
Nystatin, placebo
Arm Title
nystatin, probiotic
Arm Type
Experimental
Arm Description
nystatin, Probiotic lactobacilli reuteri
Intervention Type
Biological
Intervention Name(s)
Probiotic lactobacilli reuteri
Other Intervention Name(s)
L. reuteri (DSM 17938 og ATCC PTA 5289) two times a day
Intervention Type
Drug
Intervention Name(s)
Nystatin
Intervention Type
Drug
Intervention Name(s)
fluocinolone
Primary Outcome Measure Information:
Title
recurrence of candida infections
Time Frame
after 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptomatic Oral Lichen Planus
Exclusion Criteria:
Antibiotic treatment within 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette K Keller, PhD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus
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