lcr35® for bacterial vaginosis prevention

Conditions: Bacterial Vaginosis

Summary: this is a national, multi-centre, randomized, double-blind placebo-controlled, phase iii superiority trial. the main objective of the trial is to assess the efficacy of lcr35® by comparing the mean time before the onset of the first clinical recurrence confirmed by laboratory tests in patients with bacterial vaginosis treated with lcr35® versus placebo. patients with bacterial vaginosis will be enroll by private gynecologists. each patient will receive a treatment for the initial episode(metronidazole)and a treatment to prevent the recurrence of bacterial vaginosis (lcr35®).


Eligibility criteria:
inclusion criteria: * patient presenting with a symptomatic vaginosis characterised by the presence of the following 3 clinical criteria (among the 4 amsel criteria) at v1: * greyish uniform vaginal discharge, * characteristic "rotten fish" smell caused by the spontaneous release of amine or during the potassium test or "sniff test", * vaginal ph greater than 4.5. * patient with a nugent score ≥ 7 (using the sample taken at v1). * patient clinically cured (none of the 3 amsel criteria) after a 7-day course of metronidazole (flagyl®) female. * patient over 18 years of age. * for women with childbearing potential: * negative urine pregnancy test, * use of a contraceptive method deemed effective by the investigator (excluding spermicides). * patient having received information and voluntarily signed a written informed consent form. * patient covered by a national insurance scheme. exclusion criteria: * presence of a yeast infection that is bacterial (other than vaginosis) or viral in origin presumed or proven to be gynaecologically-linked, whether or not treated within the month preceding inclusion or present at the time of inclusion. * presence of an existing gynaecological infection that may interfere with the assessment of the trial treatment(fibroma, severe dysplasia of the cervix or in situ carcinoma, invasive carcinoma, intra-epithelial cervical neoplasia, squamous intra-epithelial lesions etc.) * antibiotics or antifungals taken by general route during the month preceding the screening visit, excluding treatment for an earlier episode of vaginosis. * use of probiotics in the month preceding the screening visit, excluding treatment for an earlier episode of vaginosis. * use of intravaginal antiseptics in the month preceding the screening visit, excluding treatment for an earlier episode of vaginosis. * use of prebiotics (acidifiers) during the two weeks preceding the screening visit. * use of products containing topical oestrogens during the month preceding the screening visit. * allergy to one of the active ingredients or one of the excipients in the products. * patient in post-menopausal time * patient unable to comply with the constraints of the protocol. * breastfeeding patient. * patient with menstrual bleeds lasting more than 12 days a month. * patient having taken part in a clinical trial in the 3 months preceding inclusion in the present protocol. * patient with a severe acute or chronic disease deemed by the investigator to be incompatible with participation in the trial, or a serious infection that is life-threatening in the short term. * immuno-suppressed patient. * patient presenting with a previous illness which, according to the investigator, is likely to interfere with the results of the trial or expose the patient to an additional risk. * patient linguistically or mentally unable to understand and sign the informed consent form. * patient deprived of her liberty by order of the courts or civil authorities or subject to a guardianship order. * patient likely not to comply with treatment. * patient unable to be contacted in the case of an emergency.