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)

Larena SAS

Status: Completed

Conditions: Vaginosis, Bacterial

Treatments: Diagnostic Test: vaginal swabs

Study type: Interventional

Funder types: Industry

Identifiers

NCT04989543

C1664

Details and patient eligibility

About

It aims to determine and compare the degree of vaginal bacterial alpha diversity in the absence (healthy population) or presence of bacterial vaginosis (pathological population).

Enrollment: 61 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

healthy population

Other group

Description:

Interventions: vaginal swabs: * Nugent scores, * cytobacteriological examination (in particular to determine the "Clue Cells") * evaluation of the vaginal microbiota. On receipt of the Nugent score results, the doctor will confirm whether or not the patient is included in one of the two arms under study: * healthy" population * pathological" population with bacterial vaginosis

Treatment:

Diagnostic Test: vaginal swabs

pathological population

Other group

Description:

Interventions: vaginal swabs: * Nugent scores, * cytobacteriological examination (in particular to determine the "Clue Cells") * evaluation of the vaginal microbiota. On receipt of the Nugent score results, the doctor will confirm whether or not the patient is included in one of the two arms under study: * healthy" population * pathological" population with bacterial vaginosis

Treatment:

Diagnostic Test: vaginal swabs