A study of the efficacy and tolerability of treatment with lyophilized whole culture of Lactobacillus casei var. rhamnosus (Lcr35 Lc) administered vaginally for the prevention of recurrence in a population of patients with recurrent bacterial vaginosis. A multicenter, international, randomized, double-blind, placebo-controlled, phase III superiority trial. - Lcr35 Lc (Gynophilus®) in the prevention of recurrent bacterial vaginosis

INTERVENTION: Product Name: Lcr35 Lc (Gynophilus®) Product Code: Lcr35 Lc (Gynophilus®) Pharmaceutical Form: Vaginal capsule* Pharmaceutical form of the placebo: Vaginal capsule* Route of administration of the placebo: Vaginal use CONDITION: recurrent bacterial vaginosis; MedDRA version: 12.1 Level: LLT Classification code 10004055 Term: Bacterial vaginosis PRIMARY OUTCOME: Main Objective: The primary objective of this study is to evaluate the efficacy of Lcr35 Lc (Gynophilus®) by comparing the reduction in the rate of clinically confirmed bacteriological recurrence at 4 months, in patients with recurrent bacterial vaginosis treated with Lcr35 Lc (Gynophilus®) versus placebo. Primary endpoint(s): The primary efficacy endpoint for this study is the presence or absence of bacteriologically proven clinical recurrence at 4 months. Secondary Objective: - To evaluate the reduction in the bacteriologically confirmed clinical recurrence rate at 2 and 6 months; - To evaluate the reduction in the clinical recurrence rate (Amsel criteria only) at 2, 4, and 6 months; - To evaluate the reduction in the number of recurrences per year per patient and the reduction in the relative risk of recurrence; - To evaluate the increase in the mean time to first bacteriologically confirmed clinical recurrence; - To evaluate the increase in the mean time to first clinical recurrence; - To evaluate the reduction in the number of days with clinical symptoms relative to the follow-up duration. - Evaluate the mean relative decrease in the number of recurrences between the 6 months preceding inclusion and the 6 months of follow-up; - Evaluate the decrease in the number of vaginosis episodes reported by the patient, adjusted for the duration of follow-up; - Evaluate the clinical tolerance of the treatment; - Evaluate the overall tolerance as judged by the investigator.