Study of the Vaginal Microbiota in Women Under Fertile Age

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-10-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Vaginal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Probiotic

Assumption of commercially available supplements containing probiotics

Probiotics

Intervention Type DIETARY_SUPPLEMENT

Assumption of commercial probiotics

Control

No assumption of supplements containing probiotics

No intervention

Intervention Type OTHER

No assumption of probiotics

Interventions

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Probiotics

Assumption of commercial probiotics

Intervention Type DIETARY_SUPPLEMENT

No intervention

No assumption of probiotics

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes