Lcr35® for Bacterial Vaginosis Prevention

Inclusion Criteria:

• Patient presenting with a symptomatic vaginosis characterised by the presence of thefollowing 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 orduring 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 ofMetronidazole (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 (excludingspermicides).

• Patient having received information and voluntarily signed a written Informed ConsentForm.

• Patient covered by a national insurance scheme.

Exclusion Criteria:

• Presence of a yeast infection that is bacterial (other than vaginosis) or viral inorigin presumed or proven to be gynaecologically-linked, whether or not treated withinthe month preceding inclusion or present at the time of inclusion.

• Presence of an existing gynaecological infection that may interfere with theassessment of the trial treatment(fibroma, severe dysplasia of the cervix or in situcarcinoma, invasive carcinoma, intra-epithelial cervical neoplasia, squamousintra-epithelial lesions etc.)

• Antibiotics or antifungals taken by general route during the month preceding thescreening visit, excluding treatment for an earlier episode of vaginosis.

• Use of probiotics in the month preceding the screening visit, excluding treatment foran earlier episode of vaginosis.

• Use of intravaginal antiseptics in the month preceding the screening visit, excludingtreatment 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 screeningvisit.

• 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 inthe present Protocol.

• Patient with a severe acute or chronic disease deemed by the Investigator to beincompatible with participation in the trial, or a serious infection that islife-threatening in the short term.

• Immuno-suppressed patient.

• Patient presenting with a previous illness which, according to the Investigator, islikely to interfere with the results of the trial or expose the patient to anadditional risk.

• Patient linguistically or mentally unable to understand and sign the Informed ConsentForm.

• Patient deprived of her liberty by order of the Courts or civil authorities or subjectto a guardianship order.

• Patient likely not to comply with treatment.

• Patient unable to be contacted in the case of an emergency.