The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus
Information source: University of Copenhagen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Oral Lichen Planus; Candida Infection
Intervention: Probiotic lactobacilli reuteri (Biological); Nystatin (Drug); fluocinolone (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of Copenhagen Official(s) and/or principal investigator(s): Mette K Keller, PhD, Principal Investigator, Affiliation: University of Copenhagen
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.
Clinical Details
Official title: The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: recurrence of candida infections
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Symptomatic Oral Lichen Planus
Exclusion Criteria:
- Antibiotic treatment within 3 months
Locations and Contacts
University of Copenhagen, Copenhagen 2100, Denmark
Additional Information
Starting date: March 2012
Last updated: December 2, 2014
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