The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus
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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 |
- 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 |
Inclusion Criteria:
- Symptomatic Oral Lichen Planus
Exclusion Criteria:
- Antibiotic treatment within 3 months
Contacts and Locations| Contact: Mette K Keller, PhD | 0045 35326527 | mke@sund.ku.dk |
| 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 | |
| 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:
|
Candidiasis Lichen Planus Lichen Planus, Oral Mycoses Lichenoid Eruptions Skin Diseases, Papulosquamous Skin Diseases Mouth Diseases Stomatognathic Diseases Fluocinolone Acetonide Nystatin Glucocorticoids |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Ionophores Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 21, 2013