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

Aphthous Stomatitis Clinical Trial

— Aphtose  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02789605
• Other study ID #: 15-PP-13
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 15, 2020
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphthous Stomatitis
• Stomatitis
• Stomatitis, Aphthous

Intervention

Drug:
• Bacilor
Patient receiving Lactobacillus rhamnosus Lcr35®, orally taken, 4 times a day, during 3 months. Then all patients will be then followed up for 3 additional months without treatment.
• Placebo
Patients of group B will took the placebo similarly at the Lactobacillus rhamnosus Lcr35® orally . All patients will be then followed up for 3 additional months without treatment.

Locations

Country	Name	City	State
France	CHU de NIce - Dermatologie	Nice	Alpes-Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of aphtae	The number of aphtae	from baseline at 3 months
Secondary	Quality of life	the impact on quality of life according to the OHIP-14 score	At 3 months
Secondary	Satisfaction patient	the satisfaction of the patients about effectiveness and safety of the treatments by EVA.	At 3 months