Clinical Trial: The Salivary and Faecal Microbiome of Recurrent Aphthous Stomatitis Patients Before and After Treatment With Probiotics

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Characterisation of the Salivary and Faecal Microbiome in Patients With Recurrent Aphthous Stomatitis Before and After Treatment With Probiotics

Brief Summary: 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.

Detailed Summary:

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.

RAS can be classified into three different types: minor, major and herpetiform. Minor RAS comprises about 80% of the cases. This type is characterised by aphthous ulcers w
Sponsor: University of Copenhagen

Current Primary Outcome:

• Beneficial effect of probiotics on the size of aphthous ulcers and the frequency of RAS outbreaks [ Time Frame: 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 [ Time Frame: 3 months ]
  Visual analogue pain scale (0-100 mm) Baseline (Day 0), Day 7 and after 30 days

Original Primary Outcome: Same as current

Current Secondary Outcome: Changes in salivary and faecal microbiome in patients with RAS due to use of probiotics [ Time Frame: 3 months ]

Original Secondary Outcome: Same as current

Information By: University of Copenhagen

Dates:
Date Received: February 7, 2016
Date Started: January 2016
Date Completion: September 2017
Last Updated: March 11, 2017
Last Verified: March 2017