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Completed

NCT Number: NCT05817292

Study of the Vaginal Microbiota in Women Under Fertile Age

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

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Key information

Conditions

Vaginal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vaginal Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Catania

Catania, 95123, Italy

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Probiotics

Dietary Supplement

Assumption of commercial probiotics

No intervention

Other

No assumption of probiotics

Primary outcomes

  1. Microbiota

    Time frame: 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)

  2. Signs

    Time frame: 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)

  3. Signs

    Time frame: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)

    Change from baseline of the Nugent score with values between 0 and 3 at the end of the treatment (10 days) and during the wash-out period (4 weeks after the end of the treatment)

  4. Symptomatology

    Time frame: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)

    Change from baseline of vulvovaginal erythema/edema, vulvar discomfort, burning, and itching

Secondary outcomes

  1. Wellbeing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Collaborators

  • ProBioEtna

Registry information

Official study title

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

Acronym: vaginalbiota

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2023
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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