Effectiveness and Safety of Lactobacillus Rhamnosus Lcr35® in the Treatment of Recurrent Aphthous Stomatitis (Aphtose)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02789605|
Recruitment Status : Completed
First Posted : June 3, 2016
Last Update Posted : November 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Aphthous Stomatitis||Drug: Bacilor Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Patient receiving Lactobacillus rhamnosus Lcr35®, orally taken, 4 times a day, during 3 months
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
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.
- number of aphtae [ Time Frame: from baseline at 3 months ]The number of aphtae
- Quality of life [ Time Frame: At 3 months ]the impact on quality of life according to the OHIP-14 score
- Satisfaction patient [ Time Frame: At 3 months ]the satisfaction of the patients about effectiveness and safety of the treatments by EVA.
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
|CHU de NIce - Dermatologie|
|Nice, Alpes-Maritimes, France, 06200|
|Principal Investigator:||Passeron Thierry, PhD||CHU de Nice, Hôpital Archet, Dermatologie|