The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus

NCT01743690 | Completed

• 1 other identifier: H-4-2011-143
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Lichen Planus; Candida Infection

Keywords

Probiotic; Candida; Oral Lichen Planus

Outcome Measures

Primary Outcomes (1)

• recurrence of candida infections

  after 1 year

Study Arms (4)

fluocinolone, placebo

ACTIVE COMPARATOR

fluocinolone, placebo

Drug: fluocinolone

fluocinolone, probiotic

EXPERIMENTAL

fluocinolone, Probiotic lactobacilli reuteri

Biological: Probiotic lactobacilli reuteri; Drug: fluocinolone

Nystatin, placebo

ACTIVE COMPARATOR

Nystatin, placebo

Drug: Nystatin

nystatin, probiotic

EXPERIMENTAL

nystatin, Probiotic lactobacilli reuteri

Biological: Probiotic lactobacilli reuteri; Drug: Nystatin

Interventions

Probiotic lactobacilli reuteri BIOLOGICAL

Also known as: L. reuteri (DSM 17938 og ATCC PTA 5289) two times a day

fluocinolone, probiotic; nystatin, probiotic

Nystatin DRUG

Nystatin, placebo; nystatin, probiotic

fluocinolone DRUG

fluocinolone, placebo; fluocinolone, probiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic Oral Lichen Planus

You may not qualify if:

• Antibiotic treatment within 3 months

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

University of Copenhagen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Lichen Planus, Oral; Candidiasis; Torulopsis

Interventions

Nystatin; fluocinolone

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Mette K Keller, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: December 6, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

DK (1)