Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT05817292
Eligibility Criteria:
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)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05817292
Study Brief:
Protocol Section:
NCT05817292