An interventional study of vaginal swabs in Vaginosis, Bacterial, sponsored by Larena SAS. Completed at 1 site in France. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-14.
Sponsored by Larena SAS · Not applicable, Interventional, and Diagnostic
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).
229 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.
This study's enrollment of 61 is below the median of 100 across 195 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →Larena SAS is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Population with bacterial vaginosis (verification of at least the following 3 criteria + Nugent score):
Presence of "Clue Cells" in the microscopic examination of fresh vaginal secretions. Clue cells are cells of the ectocervix lined with gram-negative bacilli.
Healthy population (Verification of at least 3 following criteria + Nugent score) :
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
Exclusion Criteria:
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: * 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
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.
Time frame: Day 0
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).
Time frame: Day 0
- 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.
Time frame: Day 0
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2020 to primary completion in Dec 2020, 0 months.
Of 51 interventional studies with no phase under Vaginosis, Bacterial, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 56. This study's 0 months is below that.
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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Larena SAS