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The objective of this study is to evaluate the efficacy of the consumption of the one probiotic strain in the prevention of new vaginal candidiasis events in women with recurrent vaginal candidiasis. This is a preliminary study whose purpose is to know if this probiotic is effective in reducing the number of candidiasis events and / or increasing the time between possible relapses in women diagnosed with RVVC.
Previous studies have demonstrated the effectiveness of certain probiotic strains in the treatment of vaginal candidiasis, alone or as an adjunct to antifungal treatments, as well as the effectiveness of a Lactobacillus strain as maintenance treatment after antifungal treatment to reduce the recurrence rate of candidiasis However, to date, no studies have evaluated the oral efficacy of a probiotic strain of Lactobacillus originally isolated from breast milk in the prevention of new vaginal yeast events in women with recurrent vaginal yeast infections.
The objective of this study is to evaluate the efficacy of the consumption of the one probiotic strain in the prevention of new vaginal candidiasis events in women with recurrent vaginal candidiasis. This is a preliminary study whose purpose is to know if this probiotic is effective in reducing the number of candidiasis events and / or increasing the time between possible relapses in women diagnosed with RVVC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Volunteers will take 1 capsule per day with maltodextrin for 6 months |
|
| Probiotic group | Experimental | Volunteers will take 1 capsule per day with the Lactobacillus strain for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of candidiasis events | Total candidiasis events during intervention | 6 months |
| Time between episodes | Days from baseline until candidiasis events | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of Candida in vaginal exudate by culture analysis | Analysis of the presence of Candida in vaginal exudate | 6 months |
| Microbiota of vaginal exudate | Load of Candida, Lactobacillus, Gardnerella, Prevotella, Streptococcus and Bacteroides species in vaginal exudate samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose Maldonado Lobón, PhD | Contact | +34 616556789 | jamaldonado@biosearchlife.com |
| Name | Affiliation | Role |
|---|---|---|
| Jose Maldonado Lobón, PhD | Biosearch S.A. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Infanta Elena | Valdemoro | Madrid | 28342 | Spain |
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| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Lactobacillus strain | Dietary Supplement | Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits |
|
| 6 months |
| Gynecological examination | The gynecologist will perform a gynecological examination to check:Presence of erythema of the vulva, erythema of the vaginal mucosa, lumpy, whitish-coloured vulvar oedema and excoriation of the vulva | 6 months |
| pH of vaginal discharge | Measurement of the pH of vaginal discharge | 6 months |
| Test of related clinical symptoms | The volunteers will complete a test about presence of vaginal itching, vaginal burning, whitish vaginal discharge, dysuria and dyspareunia. | 6 months |
| Intensity of the related clinical symptoms | Intensity (mild, moderate, intense) of the related clinical symptoms | 6 months |
| D014848 |
| Vulvovaginitis |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |