Clinical trial NCT04989543: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginosis, Bacterial
Keywords: Bacterial Vaginosis
Lead sponsor: Larena SAS
Sponsor class: INDUSTRY
Collaborators: name: CEN Biotech
name: Luxia Scientific
First posted: 2021-08-04
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Determine and compare the degree of vaginal bacterial alpha diversity in the absence (healthy population) or presence of bacterial vaginosis (pathological population).
timeFrame: Day 0
Secondary outcomes:
measure: Determine and compare in healthy versus pathological conditions (bacterial vaginosis) : - vaginal specific richness in enterotypes, - The diversity of vaginal bacterial species by other indices, - The overall composition of the vaginal microbiota.
timeFrame: Day 0
Other outcomes:
measure: - Identify threshold values of bacterial diversity beyond which a bacterial vaginosis would be established; - Validate these thresholds by comparison with the Nugent score and the Amsel diagnosis.
timeFrame: Day 0
Locations:
city: Paris
country: France
facility: Institut FOURNIER
Study officials:
affiliation: Larena SAS
name: Samira AIT ABDELLAH
role: STUDY_DIRECTOR
References: