Study of the Vaginal Microbiota in Women Under Fertile Age

Characterization of the Vaginal Microbiota in Fertile Age: Correlations Clinical and Pathogenetic Correlations Among Gynecological Disorders.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05817292

Acronym

vaginalbiota

Enrollment

120

Registered

2023-04-18

Start date

2022-02-01

Completion date

2022-10-30

Last updated

2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Disease

Brief summary

Characterization of the vaginal microbiota of women under fertile age and study of correlations with gynecological disorders

Detailed description

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

Interventions

DIETARY_SUPPLEMENTProbiotics

Assumption of commercial probiotics

OTHERNo intervention

No assumption of probiotics

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Age between 18 and 45 years; * Presence of at least one vaginal sign or symptom (leucorrhoea, burning, itching, and subjective vaginal discomfort); * Presence of at least 3 Amsel criteria; * Nugent score ≥ 7; * lactobacillary grade ≥ 2 (LBG) (according to Donders classification); * presence of blastospores and/or pseudohyphae evaluated by fresh mount microscopy

Exclusion criteria

* Age \< 18 years; * Nugent score \< 7; * presence of sexually transmitted disease due to Chlamydia, Neisseria gonorrhoeae, or Trichomonas vaginalis as well as specific cervico-vaginitis or severe vulvovaginal symptoms related to acute candidiasis; * Clinically apparent herpes simplex infection; * Human papillomavirus or human immunodeficiency virus infections; * Use of antibiotic, antifungal, probiotic, or immunosuppressive drugs during the past four weeks; * Use of vaginal contraceptives; * Pregnancy or breastfeeding, chronic diseases, neoplastic disease, diabetes, genital tract bleeding)

Design outcomes

Primary

Measure	Time frame	Description
Signs	Baseline; end of the treatment (10 days) ; wash-out (4 weeks)	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)
Symptomatology	Baseline; end of the treatment (10 days) ; wash-out (4 weeks)	Change from baseline of vulvovaginal erythema/edema, vulvar discomfort, burning, and itching
Microbiota	Baseline; end of the treatment (10 days) ; wash-out (4 weeks)	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)

Secondary

Measure	Time frame	Description
Wellbeing	Baseline; end of the treatment (10 days) ; wash-out (4 weeks)	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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026