An observational study in Vaginal Disease, sponsored by Universita degli Studi di Catania. Completed at 1 site in Italy. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Universita degli Studi di Catania · Observational
Characterization of the vaginal microbiota of women under fertile age and study of correlations with gynecological disorders
The study aimed to characterize, in women under fertile age, the composition and dynamics of the vaginal microbiota as well as to in-depth study correlations among microbiota and gynecological disorders
163 studies on the registry are indexed under Vaginal Diseases; 13 are open to participants now.
This study's enrollment of 120 is below the median of 200 across 17 observational studies indexed under Vaginal Diseases.
Browse Vaginal Diseases studies →Universita degli Studi di Catania is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
healthy volunteers with vaginal microbiota imbalance
Exclusion Criteria:
Assumption of commercially available supplements containing probiotics
Dietary Supplement: Probiotics
No assumption of supplements containing probiotics
Other: No intervention
Assumption of commercial probiotics
No assumption of probiotics
Microbiota
Change from baseline in the composition of the vaginal microbiota with the increase of the cell density of lactobacilli (at least 3 log units) and decrease of pathogens (at least 2 log units) at the end of the treatment (10 days) and during the wash-out period (4 weeks after the end of the treatment)
Time frame: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Signs
Change from baseline of Amsel's criteria at the end of the treatment (10 days) and during the wash-out period (4 weeks after the end of the treatment)
Time frame: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Signs
Change from baseline of the Nugent score with values between 0 and 3 at the end of the treatment (10 days) and during the wash-out period (4 weeks after the end of the treatment)
Time frame: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Symptomatology
Change from baseline of vulvovaginal erythema/edema, vulvar discomfort, burning, and itching
Time frame: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Wellbeing
Change from baseline of the quality of life based on the Short Form-36 (SF-36) questionnaire. Values ranging from 0 to 100 indicate worst and better outcomes, respectively.
Time frame: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Universita degli Studi di Catania