Vaginosis, BacterialCEBAMNCT04989543
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)
A study testing vaginal swabs in people with Vaginosis, Bacterial, run by Larena SAS at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginosis, Bacterial
- What is being tested?
- vaginal swabs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2020to 3 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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,
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- 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 locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- vaginal swabs
- Keywords
- Bacterial Vaginosis
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal swabsDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: vaginal swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
- 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).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start24 Nov 2020
- Primary completion3 Dec 2020
- Study completion3 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginosis, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larena SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEN Biotech, Luxia Scientific
- Responsible party
- Sponsor
- Investigators
- Samira AIT ABDELLAH, Study director, Larena SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989543
- Sponsor's protocol ID
- C1664
- Acronym
- CEBAM
- Status last verified
- Apr 2021
- First submitted
- 10 Mar 2021
- Last updated
- 14 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04989543
- Acronym / sponsor ID
- CEBAM / C1664
- Conditions
- Vaginosis, Bacterial
- Keywords
- Bacterial Vaginosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Larena SASIndustry (pharma, biotech, devices)
- Collaborators
- CEN Biotech, Luxia Scientific
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy population | Other | Diagnostic Test: vaginal swabsInterventions: 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 |
| pathological population | Other | Diagnostic Test: vaginal swabsInterventions: 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (13 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaginal swabsNugent 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 | Diagnostic test | healthy population, pathological population |
Primary outcome
Determine and compare the degree of vaginal bacterial alpha diversity in the absence (healthy population) or presence of bacterial vaginosis (pathological population).
Time frame: Day 0
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.
1 secondary outcome
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.
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samira AIT ABDELLAH study director
Larena SAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginal swabs in people with Vaginosis, Bacterial, run by Larena SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine and compare the degree of vaginal bacterial alpha diversity in the absence (healthy population) or presence of bacterial vaginosis (pathological population). (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.