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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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 Summary: 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.
Sponsor: Centre Hospitalier Universitaire de Nice

Current Primary Outcome: number of aphtae [ Time Frame: from baseline at 3 months ]

The number of aphtae


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life [ Time Frame: from baseline at 3 months ]
    the impact on quality of life according to the OHIP-14 score
  • Satisfaction patient [ Time Frame: from baseline at 3 months ]
    the satisfaction of the patients about effectiveness and safety of the treatments by EVA.


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Nice

Dates:
Date Received: April 14, 2016
Date Started: June 2016
Date Completion: July 2018
Last Updated: May 30, 2016
Last Verified: April 2016