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

NCT02976922 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-11-16

No results posted yet for this study

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.

Conditions

  • Recurrent Aphthous Ulcers

Interventions

DIETARY_SUPPLEMENT

Probiotic lozenge

10 patients with RAS are randomised to active treatment with probiotic lozenge, one lozenge twice daily for 3 months and other 10 patients with RAS are randomised to treatment with placebo lozenge, one lozenge twice daily for 3 months.

Sponsors & Collaborators

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Kathrine Bukkehave, Scholarstip · Department of Odontology, University of Copenhagen

  • Eric Bennett, Assoc Prof · Department of Odontology, University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-14
Primary Completion
2017-06-30
Completion
2017-07-07

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02976922 on ClinicalTrials.gov