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| Name | Class |
|---|---|
| ProBioEtna | UNKNOWN |
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Characterization of the vaginal microbiota of women under fertile age and study of correlations with gynecological disorders
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Assumption of commercially available supplements containing probiotics |
| |
| Control | No assumption of supplements containing probiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | Assumption of commercial probiotics |
| |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Women in fertile age
healthy volunteers with vaginal microbiota imbalance
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Cianci, Prof | University of Catania | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Catania | Catania | 95123 | Italy |
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| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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vaginal discharge
| No intervention |
| Other |
No assumption of probiotics |
|
| D000091662 | Genital Diseases |
| D019602 |
| Food and Beverages |