NCT02976922

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

Completed NA Last updated 16 November 2022

What this trial tests

NA trial testing Probiotic lozenge in Recurrent Aphthous Ulcers in 20 participants. Completed in 7 July 2017.

Timeline

14 March 2016

Primary endpoint
30 June 2017

7 July 2017

Quick facts

Lead sponsor	University of Copenhagen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	20
Start date	14 March 2016
Primary completion	30 June 2017
Estimated completion	7 July 2017
Sites	1 location across Denmark

Drugs / interventions tested

• Probiotic lozenge

Conditions studied

• Recurrent Aphthous Ulcers — all drugs for Recurrent Aphthous Ulcers →

Sponsor

University of Copenhagen

Who can join

Adults 18 to 30, any sex, with Recurrent Aphthous Ulcers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Delivery of biologics: Topical administration.
   Kulchar RJ, Singh R, Ding S, Alexander E, et al · · 2023 · cited 31× · PMID 37690380 · DOI 10.1016/j.biomaterials.2023.122312
2. Effect of Lozenges Containing Lactobacillus reuteri on the Severity of Recurrent Aphthous Ulcers: a Pilot Study.
   Pedersen AML, Bukkehave KH, Bennett EP, Twetman S. · · 2020 · cited 11× · PMID 31410765 · DOI 10.1007/s12602-019-09586-x