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)

NCT04989543 | Completed

• 1 other identifier: C1664
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Keywords

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

• Determine and compare the degree of vaginal bacterial alpha diversity in the absence (healthy population) or presence of bacterial vaginosis (pathological population).

  The degree of vaginal bacterial alpha diversity in healthy and pathological conditions (bacterial vaginosis) will be evaluated by the Shannon index. It will be determined by the identification of the bacterial species (16s RNA analysis) present on a vaginal swab taken during the selection visit.

  Day 0

Secondary Outcomes (1)

• 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.

  Day 0

Other Outcomes (1)

• - 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.

  Day 0

Study Arms (2)

healthy population

OTHER

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

Diagnostic Test: vaginal swabs

pathological population

OTHER

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

Diagnostic Test: vaginal swabs

Interventions

vaginal swabs 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

healthy population; pathological population

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Woman aged between ≥ 18 and ≤ 45 years old,
• 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,

You may not qualify if:

• 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 not affiliated to a social security scheme.

Sponsors & Collaborators

• Larena SAS: lead
• CEN Biotech: collaborator
• Luxia Scientific: collaborator

Study Sites (1)

Institut FOURNIER

Paris, 75014, France

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Samira AIT ABDELLAH

  Larena SAS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: August 4, 2021
• Study Start: November 24, 2020
• Primary Completion: December 3, 2020
• Study Completion: November 3, 2021
• Last Updated: December 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)