Characterisation of the Salivary and Faecal Microbiome in Patients With Recurrent Aphthous Stomatitis Before and After Treatment With Probiotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Beneficial effect of probiotics on the size of aphthous ulcers and the frequency of RAS outbreaks
研究概览
简要总结
Recurrent aphthous stomatitis (RAS) is one of the most common ulcerative diseases affecting the oral mucosa. The aetiology remains unknown, but several local, systemic, immunologic, genetic, allergic, nutritional, and microbial factors have been proposed as causative agents. Clinically, RAS is characterised by recurrent bouts of one or several rounded, shallow, painful oral ulcers at intervals of a few months or days. The aim of this study is to characterise the salivary and faecal microbiome in 20 patients with RAS and compare the findings with those of 20 healthy controls. The study also includes a double-blind randomized placebo-controlled intervention with probiotics (Lactobacillus reuteri-containing lozenges 2 tablets daily for 3 months) or placebo. The salivary and faecal microbiome in RAS patients is compared before and after treatment. This study will improve our understanding of the pathogenesis in RAS and provide us with knowledge on potential future therapeutic approaches.
详细描述
Purpose of the study The purpose of this study is to characterise the salivary and faecal microbiome in patients with recurrent aphthous stomatitis (RAS) and to compare the findings to those of a matched healthy control group. Another purpose is to investigate the effect of treatment with probiotics on the microbiome in whole saliva and faeces as well as the severity and number of RAS outbreaks. Moreover, a smear will be taken from present aphthous ulcers before and after treatment with probiotics in order to characterise the local microbiota.
It is assumed that the microbiome in whole saliva and faeces from patients with RAS (minor or major type aphthous ulcers) differs from the microbiome in whole saliva and faeces from age- and gender-matched control persons.
It is also hypothesised that probiotic treatment has a beneficial effect on the mucosal pain and reduces the severity of RAS and the frequency of outbreaks. Furthermore, it is assumed that treatment with probiotic has an effect on microbiome in whole saliva and faeces from patients with RAS.
Background Recurrent aphthous stomatitis (RAS) is one of the most common ulcerative diseases affecting the oral mucosa. The prevalence varies from 5-25%. The aetiology remains unknown, but several local, systemic, immunologic, genetic, allergic, nutritional, and microbial factors have been proposed as causative agents.
Clinically, RAS is characterised by recurrent bouts of one or several rounded, shallow, painful oral ulcers at intervals of a few months or days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Autoimmune diseases/immunosuppressive conditions
- •Treatment with immunosuppressant
- •Current treatment with antibiotics
- •Drug and/or alcohol abuse
- •Pregnancy
- •Current use of oral rinses
- •Current use of topical steroids or other agents for relief oral symptoms
结局指标
主要结局
Beneficial effect of probiotics on the size of aphthous ulcers and the frequency of RAS outbreaks
时间窗: 3 months
Measurements of the size and numbers of aphthous ulcers (in mm, using scoring system) Baseline (Day 0), Day and after 30 days
Beneficial effect of probiotics on oral pain related to aphthous ulcers
时间窗: 3 months
Visual analogue pain scale (0-100 mm) Baseline (Day 0), Day 7 and after 30 days
次要结局
- Changes in salivary and faecal microbiome in patients with RAS due to use of probiotics(3 months)
研究者
Anne Marie Lynge Pedersen
Associate Professor, PhD, DDS
University of Copenhagen