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

NCT ID: NCT02789605

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-04

Study Completion Date

2020-07-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aphthous Stomatitis

Keywords

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Aphthous Stomatitis [C07.465.864.750]

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bacilor

Patient receiving Lactobacillus rhamnosus Lcr35®, orally taken, 4 times a day, during 3 months

Group Type EXPERIMENTAL

Bacilor

Intervention Type DRUG

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

Patient receiving placebo, orally taken, 4 times a day, during 3 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Passeron Thierry, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Nice, Hôpital Archet, Dermatologie

Locations

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CHU de NIce - Dermatologie

Nice, Alpes-Maritimes, France

Site Status

Countries

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France

Other Identifiers

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15-PP-13

Identifier Type: -

Identifier Source: org_study_id