The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus

Status Completed

Clinical 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.

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 Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01743690
Study type	Interventional
Source	University of Copenhagen
Contact
Status	Completed
Phase	N/A
Start date	March 2012
Completion date	December 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05997173` - The Regulatory Role of Immune Response in Oral Lichen Planus
Completed	`NCT02443311` - Clinical and Immunohistochemical Effect of Topical Pimecrolimus in Treatment of Oral Lichen Planus	Phase 4
Completed	`NCT00484250` - Study of Metronidazole and Doxycycline to Treat Oral Lichen Planus and to Compare Their Efficacy With Each Other	Phase 2
Completed	`NCT03682562` - Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions
Completed	`NCT04193748` - Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)	Phase 4
Completed	`NCT04153266` - Oral Epithelial Dysplasia Informational Needs Questionnaire
Recruiting	`NCT06135805` - Impact of Fluocinonide 0,05% in Oral Lichen Planus	N/A
Completed	`NCT04289233` - Molecular & Cellular Characterisation of Oral Lichen Planus
Completed	`NCT04293718` - Acquired Chronic Erosive Gingivitis: Clinical Relevance of Papillary Gingival Biopsy
Completed	`NCT00525421` - A Clinical Study of Curcuminoids in the Treatment of Oral Lichen Planus	Phase 2
Not yet recruiting	`NCT04091698` - Clinical and Biochemical Assessment of the Effect of Topical Use of Coenzyme Q10 Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Randomized Controlled Clinical Trial	Phase 1
Completed	`NCT03386643` - Effect of Bifidobacterium Animalis Subsp. Lactis HN019 on Oral Lichen Planus	Phase 2
Withdrawn	`NCT03836885` - Apremilast - Oral Lichen Planus Trial	Phase 2
Completed	`NCT05730855` - Diagnostic Accuracy of lncRNA DQ786243 and miRNA146a in Saliva of Oral Potentially Malignant Lesions
Completed	`NCT03257228` - The Association Between Diabetes Mellitus, Oral Lichen Planus and Insulin-like Growth Factors 1 and 2 (IGF1 and IGF2)	N/A
Recruiting	`NCT03026478` - Topical Betamethasone and Clobetasol in Orabase in Oral Lichen Planus	Phase 2
Completed	`NCT02858297` - Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus	Phase 4
Completed	`NCT02834520` - Expression of miRNa-138 and Cyclin D1 in Oral Mucosa of Patients With Oral Lichen Planus	N/A
Completed	`NCT02106468` - The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus	Phase 2
Recruiting	`NCT00737854` - Free Soft Tissue Graft in Treatment of Oral Lichen Planus	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.