Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02789605 |
Other study ID # |
15-PP-13 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
January 4, 2018 |
Est. completion date |
July 15, 2020 |
Study information
Verified date |
December 2019 |
Source |
Centre Hospitalier Universitaire de Nice |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.