Effect of Lozenges Containing Lactobacillus reuteri on the Severity of Recurrent Aphthous Ulcers: a Pilot Study
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Effect of Lozenges Containing Lactobacillus reuteri on the Severity of Recurrent Aphthous Ulcers: a Pilot Study Anne Marie Lynge Pedersen 1
&
Kathrine Hansen Bukkehave 1 & Eric Paul Bennett 1 & Svante Twetman 1
# Springer Science+Business Media, LLC, part of Springer Nature 2019
Abstract To investigate the effect of a probiotic supplement on the severity of aphthous lesions in patients with recurrent aphthous stomatitis (RAS) over a 3-month period. A second endpoint was to study the effect on pain related to the lesions. The study employed a double-blind randomized, placebo-controlled design with two parallel arms. Twenty patients with minor and major RAS were consecutively enrolled and randomly assigned to the test or the control group. The intervention consisted of lozenges containing two strains of Lactobacillus reuteri taken twice daily for 90 days. Ulcer Severity Score (USS) consisting of six lesion characteristics (number, size, duration, ulcer-free period, site, and pain) was calculated at baseline and after the intervention. Oral pain related to the lesions was estimated by the patients with a Visual Analogue Pain Scale. An improvement of the USS, as well as oral pain, was evident in both groups after 90 days but the reduction was only statistically significant (p < 0.05) compared with baseline in the test group. There were no significant differences between the groups, neither at baseline nor at follow-up. No side effects were recorded. Daily supplements with L. reuteri reduced the severity of aphthous lesions over a 90-day period but the improvement was not significantly better than placebo. The results encourage further research and provide a basis for power calculations of larger and extended studies. ClinicalTrials.gov Identifier: NCT02976922 Keywords RAS . Lactobacillus . Probiotics . Oral mucosal pain
Introduction Recurrent aphthous stomatitis (RAS) is one of the most common ulcerative diseases affecting the oral mucosa with a prevalence ranging from 5 to 25% in children [1–3]. However, up to 66% of young adults give a history consistent with recurrent aphthous ulceration [4]. The etiology remains unknown, but a number of local and systemic factors are assumed to increase the predisposition, including mucosal trauma, stressful events, hormonal changes, smoking cessation, allergy to various food substances, as well as vitamin and/or mineral deficiency [1, 2]. Furthermore, microbial factors have been proposed as causative agents and there is also a genetic predisposition; the possibility of developing RAS is 90% if both parents have RAS and 20% if one of the parents has RAS. Clinically, RAS is
* Anne Marie Lynge Pedersen [email protected] 1
Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Nørre Allé 20, 2200 Copenhagen N, Denmark
characterized by recurrent bouts of one or several rounded, shallow, painful oral ulcers at intervals of a few months or days that heal after 7 to 10 days without scarring [4]. A number of systemic and topical treatments for RAS
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