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)

NCT ID: NCT04989543

Last Updated: 2021-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-24
• Study Completion Date: 2021-11-03

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).

Conditions

Vaginosis, Bacterial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

healthy population

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

Group Type: OTHER

vaginal swabs

Intervention Type: DIAGNOSTIC_TEST

Nugent score: Vaginal swabbing with the dry swab, make two smears on slides.

Cytobacteriological examination: swabbing at the exo-endocrine junction using the swab

Evaluation of the vaginal microbiota: swabbing at the exo-endocrine junction using the swab

pathological population

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

Group Type: OTHER

vaginal swabs

Intervention Type: DIAGNOSTIC_TEST

Nugent score: Vaginal swabbing with the dry swab, make two smears on slides.

Cytobacteriological examination: swabbing at the exo-endocrine junction using the swab

Evaluation of the vaginal microbiota: swabbing at the exo-endocrine junction using the swab

Interventions

vaginal swabs

Nugent score: Vaginal swabbing with the dry swab, make two smears on slides.

Cytobacteriological examination: swabbing at the exo-endocrine junction using the swab

Evaluation of the vaginal microbiota: swabbing at the exo-endocrine junction using the swab

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Larena SAS

INDUSTRY

Sponsor Role: lead

CEN Biotech

INDUSTRY

Sponsor Role: collaborator

Luxia Scientific

INDUSTRY

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samira AIT ABDELLAH

Role: STUDY_DIRECTOR

Larena SAS

Locations

Institut FOURNIER

Paris, , France

Countries

France

Other Identifiers

C1664

Identifier Type: -

Identifier Source: org_study_id