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. 2023 Jan 9;9:1075612. doi: 10.3389/fsurg.2022.1075612

Table 1.

Description of inclusion and exclusion criteria.

Inclusion Criteria Exclusion Criteria
Fertile age (18–45 years). Presence of sexually transmitted disease due to Chlamydia, Neisseria gonorrhoeae or Trichomonas vaginalis.
Presence of at least one vaginal symptom: (leucorrhoea, burning, itching, erythema/edema or subjective vaginal discomfort). Presence of specific vaginitis related to acute candidiasis.
Clinical evidence of vaginal dysbiosis: [at least 3 Amsel criteria or Nugent score ≥7 or lactobacillary grade (LBG) ≥ 2]. Clinically apparent herpes simplex infection.
Signed informed consent. Precancerous lesions due to Human papillomavirus.
Not participating in other clinical studies. Human immunodeficiency virus infection
Willingness to take the investigational product or placebo. Confirmed diagnosis of pelvic inflammatory disease (PID).
Willingness to collaborate in completing the study procedures. Recent use of antibiotic, antifungal drugs (less than one month)
  Recent consumption of probiotics or food containing probiotics.
  Recent use immunosuppressive drugs (less than one month).
  Actual or recent use of vaginal contraceptives.
  Pregnancy or breastfeeding.
  Use of douching.
  Hypersensitivity or allergy to any ingredient of investigational product or placebo.
  Chronic diseases.
  Neoplastic disease.
  Diabetes
  Genital tract bleeding.