Study of the Vaginal Microbiota in Women Under Fertile Age (vaginalbiota)

Universita degli Studi di Catania

Status

Completed

Conditions

Vaginal Disease

Treatments

Other: No intervention

Dietary Supplement: Probiotics

Study type

Observational

Funder types

Other

Identifiers

NCT05817292

16/2022/PO

Details and patient eligibility

About

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

Full 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

Enrollment

120 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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)