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

• ClinicalTrials.gov Identifier: NCT02789605
• Recruitment Status: Completed
• First Posted: June 3, 2016
• Last Update Posted: November 10, 2020
• Sponsor: Centre Hospitalier Universitaire de Nice
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Nice

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Aphthous Stomatitis	Drug: Bacilor; Drug: Placebo	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Treatment of Idiopathic and Recurrent Aphthous Stomatitis by a Probiotic, the Lactobacillus Rhamnosus Lcr35® : a Randomized, Double Blind and Placebo-controlled Trial
• Actual Study Start Date: January 4, 2018
• Actual Primary Completion Date: November 25, 2019
• Actual Study Completion Date: July 15, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Bacilor; Patient receiving Lactobacillus rhamnosus Lcr35®, orally taken, 4 times a day, during 3 months	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 Comparator: Placebo; Patient receiving placebo, orally taken, 4 times a day, during 3 months	Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. number of aphtae [ Time Frame: from baseline at 3 months ]
   The number of aphtae

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

CHU de NIce - Dermatologie

Nice, Alpes-Maritimes, France, 06200

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

• Principal Investigator: Passeron Thierry, PhD; CHU de Nice, Hôpital Archet, Dermatologie

More Information

• Responsible Party: Centre Hospitalier Universitaire de Nice
• ClinicalTrials.gov Identifier: NCT02789605
• Other Study ID Numbers: 15-PP-13
• First Posted: June 3, 2016
• Last Update Posted: November 10, 2020
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Nice:

Aphthous Stomatitis [C07.465.864.750]

Additional relevant MeSH terms:

Stomatitis; Stomatitis, Aphthous; Mouth Diseases; Stomatognathic Diseases