Effectiveness and Safety of Lactobacillus Rhamnosus Lcr35® in the Treatment of Recurrent Aphthous Stomatitis
Effectiveness and Safety of Lactobacillus Rhamnosus Lcr35® in the Treatment of Recurrent Aphthous Stomatitis
Recurrent aphthous stomatitis (RAS) is a frequent condition characterized by recurrent and
 painful oral ulcers with unknown pathophysiology. Recent studies suggest that a dysregulation
 of the oral microbiota may be implicated. Currently, therapies for RAS are limited by severe
 side effects or inconstant effectiveness. The aim of this study is to assess the
 effectiveness and safety of a probiotic, the Lactobacillus rhamnosus Lcr35® , in the
 treatment of RAS. A placebo-controlled, parallel study will be conducted in 40 subjects with
 RAS. Treatment consisted on the administration of the daily probiotics or placebo during 3
 months.All patients will be then followed up for additional 3months without treatment. The
 main outcome measure will be the number of occurring aphtae.
Recurrent aphthous stomatitis (RAS) is the most common chronic disease of the oral cavity,
 affecting 5-25% of the population. This condition is characterized by recurrent and painful
 oral ulcers. The discomfort of RAS can impact negatively on quality of life that is why the
 therapeutic demand is strong. Currently, there is no curative treatment for RAS, and
 suspensive treatments such as colchicine and thalidomide are no definitive or can induce
 severe side effects. The pathophysiology of RAS remains largely unknown. Recent studies
 suggest that a dysregulation of the oral microbiota may be implicated. Increasing data
 underline the potential interest of using probiotics in conditions due to microbiota
 disorder. To the best of our knowledge, no study has evaluated the effectiveness of probiotic
 in RAS. The main objective of this double blind clinical trial is to evaluate the
 effectiveness and safety of a probiotic, the Lactobacillus rhamnosus Lcr35®, in the treatment
 of RAS in adults. 40 patients suffering from minor RAS for 6 months will be included and
 randomly assigned to 2 group of 20. Patients of group A will took the Lactobacillus rhamnosus
 Lcr35® orally daily for 3 months and patients of group B will took the placebo similarly. All
 patients will be then followed up for 3 additional months without treatment. The primary
 outcome measure will be the monthly number of aphthae occurring during the 3 months of
 treatment. The secondary outcomes measures will be the monthly number of aphthae occurring
 during the 3 months of follow up, the pain reduction, the impact on quality of life according
 to the OHIP-14 score and the side effects.
Inclusion Criteria:

 -  18 year-old or more

 -  Recurrent idiopathic aphtous stomatitis with at least one new lesion per month during
 the past 6 months.

 Exclusion Criteria:

 -  Symptomatic aphtosis associated with Crohn or Behcet disease

 -  Concomitant use of probiotic for any other reason

 -  Systemic use of colchicine or steroids or immunosuppressive drugs during the past 3
 months