Study of the Vaginal Microbiota in Women Under Fertile Age

Universita degli Studi di Catania120 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Vaginal Disease

Interventions

ProbioticsDIETARY_SUPPLEMENT

Assumption of commercial probiotics

No interventionOTHER

No assumption of probiotics

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

University of Catania

Catania, Italy

Outcomes

Primary Outcomes

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)