Study of the Composition and Bacterial Diversity of the Vaginal Microbiota in Healthy Versus Pathological Conditions (Bacterial Vaginosis) Using a Targeted Metagenomic Approach (RNA 16s) (CEBAM)

This is an interventional diagnostic trial for Vaginosis, Bacterial focused on measuring Bacterial Vaginosis Read More

Inclusion Criteria:

• Woman aged between ≥ 18 and ≤ 45 years old,
• In good general health (outside the gynaecological sphere), i.e. no chronic pathology and not taking medication at the time of inclusion and/or long-term,
• Woman with a healthy or pathological vaginal flora according to Amsel's clinical diagnosis and Nugent's score :

Population with bacterial vaginosis (verification of at least the following 3 criteria + Nugent score):

• Vaginal pH > 4.5
• greyish, homogenous vaginal secretions adhering to the vaginal wall
• characteristic vaginal odour of "rotten fish" after contact of the vaginal discharge with a few drops of 10% potash ("sniff test")

• Presence of "Clue Cells" in the microscopic examination of fresh vaginal secretions. Clue cells are cells of the ectocervix lined with gram-negative bacilli.

  • Nugent Score ≥ 7

Healthy population (Verification of at least 3 following criteria + Nugent score) :

• Absence of vaginal pH > 4.5
• No greyish, homogenous vaginal secretions adhering to the vaginal wall
• No characteristic vaginal odour of "rotten fish" after contact of the vaginal discharge with a few drops of 10% potash ("sniff test").

• Absence of "Clue Cells" on microscopic examination of fresh vaginal secretions. Clue cells" are cells of the ectocervix lined with gram-negative bacilli.

  • Nugent Score ≤3

    • Able and willing to participate in the research by complying with the procedures of the protocol, especially regarding vaginal sampling,
    • Having given its free, informed and written consent.

Exclusion Criteria:

• Patient during menstruation,
• Patient who has had vaginal sex within 48 hours,
• Patient with irregular menstrual cycles,
• Patient undergoing preventive or curative treatment for vaginal infections,
• Patients suffering from other diseases of the vagina (herpes, chlamydia, syphillis),
• Patients undergoing antibiotic or antifungal treatments or taken less than 3 months ago,
• Patient under probiotic or prebiotic complementation or taken less than a month ago,
• Patient with systemic or immunodeficient disease,
• Patient with an alcohol consumption of more than 2 glasses per day,
• Pregnant or breastfeeding woman, or woman planning to become pregnant within the next 8 weeks, or woman in the post-partum period,
• Patient unable to understand information related to the study (mental or linguistic disability),
• Patient participating or having participated within the previous 3 months in another clinical trial, or in a period of exclusion from a clinical trial,
• Patient not affiliated to a social security scheme.