drugset / Trial / NCT02789605

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

NCT02789605 ↗

Phase 2 Completed 20 enrolled Centre Hospitalier Universitaire de Nice
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2018-01-04
Primary completion
2019-11-25
Completion
2020-07-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactobacillus Rhamnosus Lcr35® Other / unclassified — Oral

Indications