Effectiveness and Safety of Lactobacillus Rhamnosus Lcr35® in the Treatment of Recurrent Aphthous Stomatitis

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Brief Title

Effectiveness and Safety of Lactobacillus Rhamnosus Lcr35® in the Treatment of Recurrent Aphthous Stomatitis

Official Title

Treatment of Idiopathic and Recurrent Aphthous Stomatitis by a Probiotic, the Lactobacillus Rhamnosus Lcr35® : a Randomized, Double Blind and Placebo-controlled Trial

Brief Summary

      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.
    

Detailed Description

      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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

number of aphtae

Secondary Outcome

 Quality of life

Condition

Aphthous Stomatitis

Intervention

Bacilor

Study Arms / Comparison Groups

 Bacilor
Description:  Patient receiving Lactobacillus rhamnosus Lcr35®, orally taken, 4 times a day, during 3 months

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

January 4, 2018

Completion Date

July 15, 2020

Primary Completion Date

November 25, 2019

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Passeron Thierry, PhD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02789605

Organization ID

15-PP-13


Responsible Party

Sponsor

Study Sponsor

Centre Hospitalier Universitaire de Nice


Study Sponsor

Passeron Thierry, PhD, Principal Investigator, CHU de Nice, Hôpital Archet, Dermatologie


Verification Date

December 2019