aphtous stoma
Conditions
Interventions
Trade Name: Bacilor Lactobacillus casei variété rhamnosus Lcr35®
Product Name: Bacilor Lactobacillus casei variété rhamnosus Lcr35®
Product Code: Probionov
Pharmaceutical Form: Powder for oral suspens
Sponsors
CHU NICE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients older than 18 years old with recurrent and idiopathic aphtous stomatitis. They must have a medical history of recurrent minor aphthous ulcer for at least 6 months with a frequency of at least 1 flare per month Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Use of a probiotic for any other reason. Immunosuppression. Aphtous ulcers as manifestation of systemic disorders such as ulcerative colitis, Crohn disease, Behcet syndrome. Use of medications such as systemic steroids or immunomodulatory agents or colchicine during the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effectiveness of a probiotic (Lactobacillus rhamnosus Lcr35®, Bacilor®) for the treatment of recurrent and idiopathic aphtous stomatitis compared to placebo after 3 months of treatment (M3);Secondary Objective: 1 / To evaluate the effectiveness of a probiotic (Lactobacillus rhamnosus Lcr35®, Bacilor®) for the treatment of recurrent and idiopathic aphtous stomatitis compared to placebo 3 months after the discontinuation of the treatment (M6) 2 / To evaluate the effectiveness on the pain of a probiotic (Lactobacillus rhamnosus Lcr35®, Bacilor®) for the treatment of recurrent and idiopathic aphtous stomatitis compared to placebo after 3 months of treatment (M3) and 3 months after the discontinuation of the treatment (M6). 3 / To compare the satisfaction of the patients on the efficiency and safety of the treatments after 3 months of treatment (M3) 4 / To evaluate the impact on quality of life of a probiotic (Lactobacillus rhamnosus Lcr35®, Bacilor®) for the treatment of recurrent and idiopathic aphtous stomatitis compared to placebo after 3 months of treatment (M3) and 3 months after the discontinuation of the treatment (M6). 5 / To study the possible side effects during treatment;Primary end point(s): The primary outcome measure is the monthly number of new aphtous ulcers (incidental events) during the 3 months of treatment (D0, M1, M2 and M3 );Timepoint(s) of evaluation of this end point: at D0, M1, M2 and M3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 / The monthly number of new aphtous ulcers (incidental events) during the 3 months of follow up without treatment (M4, M5 and M6) 2 / The average monthly pain evaluated by analogical visual scale during the 3 months of treatment (M1, M2 and M3) 3 / The satisfaction of the patients on the efficiency and the safety of the treatments after 3 months of treatment (M3) evaluated on a visual analogical scale 4 / The oral health-related quality of life evaluated with the Oral Health Impact Profile 14 after 3 months of treatment (M3) and 3 months after the discontinuation of the treatment (M6). 5 / The frequency, severity and occurrence of side effects will be noted. ;Timepoint(s) of evaluation of this end point: 1 / During the 3 months of follow up without treatment (M4, M5 and M6) 2 / During the 3 months of treatment (M1, M2 and M3) 3 / After 3 months of treatment (M3) evaluated on a visual analogical scale 4 / At M3 and 3 months after the discontinuation of the treatment (M6). 5 / At each visit | — |
Countries
France
Contacts
Public ContactMme Caillon
CHU de Nice
Outcome results
None listed