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

NCT02789605 | Completed Phase 2

• 1 other identifier: 15-PP-13
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphthous Stomatitis

Keywords

Aphthous Stomatitis [C07.465.864.750]

Outcome Measures

Primary Outcomes (1)

• number of aphtae

  The number of aphtae

  from baseline at 3 months

Secondary Outcomes (2)

• Quality of life

  At 3 months

• Satisfaction patient

  At 3 months

Study Arms (2)

Bacilor

EXPERIMENTAL

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

Drug: Bacilor

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Bacilor 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.

Bacilor

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year-old or more
• Recurrent idiopathic aphtous stomatitis with at least one new lesion per month during the past 6 months.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de NIce - Dermatologie

Nice, Alpes-Maritimes, 06200, France

Location

Related Publications (1)

• Dugourd PM, Martin H, Fontas E, Velin M, Montaudie H, Lacour JP, Passeron T. Probiotics for recurrent idiopathic aphthous stomatitis in adults: a placebo-controlled randomized trial. J Eur Acad Dermatol Venereol. 2020 May;34(5):e239-e240. doi: 10.1111/jdv.16199. Epub 2020 Feb 16. No abstract available.

  PMID: 31954066 RESULT

MeSH Terms

Conditions

Stomatitis, Aphthous

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Passeron Thierry, PhD

  CHU de Nice, Hôpital Archet, Dermatologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: June 3, 2016
• Study Start: January 4, 2018
• Primary Completion: November 25, 2019
• Study Completion: July 15, 2020
• Last Updated: March 24, 2026

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)