Institut FOURNIER
Paris, 75014, France
NCT Number: NCT04989543
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).
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Paris, 75014, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Population with bacterial vaginosis (verification of at least the following 3 criteria + Nugent score):
Healthy population (Verification of at least 3 following criteria + Nugent score) :
Exclusion criteria
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
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.
Time frame: Day 0
Time frame: Day 0
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.
Larena SAS
Industry
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)
Acronym: CEBAM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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