The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Copenhagen
Sponsor:
Information provided by (Responsible Party):
Mette Kirstine Keller, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01743690
First received: November 28, 2012
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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 Intervention
Oral Lichen Planus
Candida Infection
Biological: Probiotic lactobacilli reuteri
Drug: Nystatin
Drug: fluocinolone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • recurrence of candida infections [ Time Frame: after 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic Oral Lichen Planus

Exclusion Criteria:

  • Antibiotic treatment within 3 months
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743690

Contacts
Contact: Mette K Keller, PhD 0045 35326527 mke@sund.ku.dk

Locations
Denmark
University of Copenhagen Recruiting
Copenhagen, Denmark, 2100
Contact: Mette K Keller, PhD    0045 35326527    mke@sund.ku.dk   
Principal Investigator: Mette K Keller, PhD         
Sub-Investigator: Camilla Kragelund, PhD         
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Mette K Keller, PhD University of Copenhagen
  More Information

No publications provided

Responsible Party: Mette Kirstine Keller, Assistant professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01743690     History of Changes
Other Study ID Numbers: H-4-2011-143
Study First Received: November 28, 2012
Last Updated: December 5, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
Probiotic
Candida
Oral Lichen Planus

Additional relevant MeSH terms:
Lichen Planus
Lichen Planus, Oral
Candidiasis
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Mycoses
Fluocinolone Acetonide
Nystatin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014