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The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01743690
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : December 11, 2015
Information provided by (Responsible Party):
Mette Kirstine Keller, University of Copenhagen

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.

Condition or disease Intervention/treatment Phase
Oral Lichen Planus Candida Infection Biological: Probiotic lactobacilli reuteri Drug: Nystatin Drug: fluocinolone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus
Study Start Date : March 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections
Drug Information available for: Nystatin

Arm Intervention/treatment
Active Comparator: fluocinolone, placebo
fluocinolone, placebo
Drug: fluocinolone
Experimental: fluocinolone, probiotic
fluocinolone, Probiotic lactobacilli reuteri
Biological: Probiotic lactobacilli reuteri
Other Name: L. reuteri (DSM 17938 og ATCC PTA 5289) two times a day

Drug: fluocinolone
Active Comparator: Nystatin, placebo
Nystatin, placebo
Drug: Nystatin
Experimental: nystatin, probiotic
nystatin, Probiotic lactobacilli reuteri
Biological: Probiotic lactobacilli reuteri
Other Name: L. reuteri (DSM 17938 og ATCC PTA 5289) two times a day

Drug: Nystatin

Primary Outcome Measures :
  1. recurrence of candida infections [ Time Frame: after 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Symptomatic Oral Lichen Planus

Exclusion Criteria:

  • Antibiotic treatment within 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01743690

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University of Copenhagen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
University of Copenhagen
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Principal Investigator: Mette K Keller, PhD University of Copenhagen
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Responsible Party: Mette Kirstine Keller, Assistant professor, University of Copenhagen Identifier: NCT01743690    
Other Study ID Numbers: H-4-2011-143
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015
Keywords provided by Mette Kirstine Keller, University of Copenhagen:
Oral Lichen Planus
Additional relevant MeSH terms:
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Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Fluocinolone Acetonide
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action