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临床试验/NCT01743690
NCT01743690已完成不适用

The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
recurrence of candida infections

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Symptomatic Oral Lichen Planus

排除标准

  • Antibiotic treatment within 3 months

研究组 & 干预措施

fluocinolone, placebo

Active Comparator

fluocinolone, placebo

干预措施: fluocinolone (Drug)

fluocinolone, probiotic

Experimental

fluocinolone, Probiotic lactobacilli reuteri

干预措施: Probiotic lactobacilli reuteri (Biological)

fluocinolone, probiotic

Experimental

fluocinolone, Probiotic lactobacilli reuteri

干预措施: fluocinolone (Drug)

Nystatin, placebo

Active Comparator

Nystatin, placebo

干预措施: Nystatin (Drug)

nystatin, probiotic

Experimental

nystatin, Probiotic lactobacilli reuteri

干预措施: Probiotic lactobacilli reuteri (Biological)

nystatin, probiotic

Experimental

nystatin, Probiotic lactobacilli reuteri

干预措施: Nystatin (Drug)

结局指标

主要结局

recurrence of candida infections

时间窗: after 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mette Kirstine Keller

Assistant professor

University of Copenhagen

研究点 (1)

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