Lcr35® for Bacterial Vaginosis Prevention

Study Overview
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Brief Summary
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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®).

Official Title
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Study of the Efficacy and Safety of Treatment With Total Freeze-dried Culture of Lactobacillus Casei Var. Rhamnosus (Lcr35®) Administered Intravaginally in the Prevention of Bacterial Vaginosis. Randomized, Phase III, Multi-centre, Double-blind, Placebo-controlled Superiority Trial

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Drug: placebo
* Drug: Lcr35®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lcr35®<br> | Drug: Lcr35®<br>* 1x14-day course of treatment during 4 cycles<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* 1x14-day course of treatment during 4 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean time before the onset of first clinical recurrence confirmed by laboratory tests |  | 4 months |