Study of the Vaginal Microbiota in Women Under Fertile Age

Study Overview
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Brief Summary
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Characterization of the vaginal microbiota of women under fertile age and study of correlations with gynecological disorders

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

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

Conditions
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Vaginal Disease

Intervention / Treatment
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* Dietary Supplement: Probiotics
* Other: No intervention


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Probiotic<br>Assumption of commercially available supplements containing probiotics | Dietary Supplement: Probiotics<br>* Assumption of commercial probiotics<br>|
| Control<br>No assumption of supplements containing probiotics | Other: No intervention<br>* No assumption of probiotics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiota | 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) | Baseline; end of the treatment (10 days) ; wash-out (4 weeks) | 
| Signs | 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) | Baseline; end of the treatment (10 days) ; wash-out (4 weeks) | 
| Signs | 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) | Baseline; end of the treatment (10 days) ; wash-out (4 weeks) | 
| Symptomatology | Change from baseline of vulvovaginal erythema/edema, vulvar discomfort, burning, and itching | Baseline; end of the treatment (10 days) ; wash-out (4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wellbeing | 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. | Baseline; end of the treatment (10 days) ; wash-out (4 weeks) |