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

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ClinicalTrials.gov Identifier: NCT02789605
Recruitment Status : Recruiting
First Posted : June 3, 2016
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Canker Sores

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.




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: from baseline at 3 months ]
    the impact on quality of life according to the OHIP-14 score

  2. Satisfaction patient [ Time Frame: from baseline at 3 months ]
    the satisfaction of the patients about effectiveness and safety of the treatments by EVA.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789605


Contacts
Contact: Passeron Thierry, PhD 0033492036488 passeron.t@chu-nice.fr

Locations
France
CHU de NIce - Dermatologie Recruiting
Nice, Alpes-Maritimes, France, 06200
Contact: Passeron Thierry, PhD    0033492036488    passeron.t@chu-nice.fr   
Principal Investigator: Passeron Thierry, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Passeron Thierry, PhD CHU de Nice, Hôpital Archet, Dermatologie

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02789605     History of Changes
Other Study ID Numbers: 15-PP-13
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
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