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 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)

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).

Study Overview

• Status: Completed
• Conditions: Vaginosis, Bacterial
• Intervention / Treatment: Diagnostic test: vaginal swabs

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Institut FOURNIER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Diagnostic test: 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
Other: 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	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Enterotypic richness will be assessed by 16 S analyses on the vaginal swab taken during the selection visit.; The α-diversity will be calculated using other indices.; The overall composition of the vaginal microbiota will be assessed from a taxonomic point of view on the vaginal swab taken during the selection visit by calculating the percentage (relative quantification).	Day 0

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
- 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.	The possible thresholds of bacterial diversity above which bacterial vaginosis is observed will be validated by comparison with the Nugent score made during the screening visit and the Amsel diagnosis.	Day 0

Collaborators and Investigators

• Sponsor: Larena SAS
• Collaborators: CEN Biotech; Luxia Scientific
• Investigators: Study Director: Samira AIT ABDELLAH, Larena SAS

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Actual): December 3, 2020
• Study Completion (Actual): November 3, 2021

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Bacterial Vaginosis
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial
• Other Study ID Numbers: C1664

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No