Overview

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

Status:
Completed

Trial end date:
2020-07-15

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Centre Hospitalier Universitaire de Nice

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