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| Name | Class |
|---|---|
| University of Natural Resources and Life Sciences, Vienna, Austria | OTHER |
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The aim of this study is the improvement of the penile linked neovaginal flora in male-to-female transsexuals after application of oral probiotics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacilli | Active Comparator | 30 Participants with verum |
|
| Placebo | Placebo Comparator | 30 Participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | lyophilised L. rhamnosus, L. jensenii, L. crispatus, L. gasseri and sodium alginate |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in Nugent score between baseline and end of treatment (improvement or no improvement). | Using Nugent scoring system, from each participant first swab from neovagina and rectum will be taken before start of oral probiotic use.(baseline information) Second swab from neovagina and rectum will be taken on the day following the last administration.(information about change in Nugent) | day 0 day 7 of oral probiotic application |
| Measure | Description | Time Frame |
|---|---|---|
| Isolation of specific Lactobacilli from neovaginal microbiologic cultures after oral administration of probiotic | From each participant, the swab from neovagina and rectum for microbiologic cultures will be taken on the day following the last administration. Isolation of oral applied probiotic strains. | Day 7 of oral probiotic application |
| Measure | Description | Time Frame |
|---|---|---|
| Nugent Score | day 0 day 7 of oral probiotic application |
Inclusion Criteria:
Participants underwent the sex reassignment surgery (SRS) with the technique of the inverted penile skin flap longer than 1 year.
All transsexual women treated according to the Standards of Care of the World Professional Association of Transgender Health (WPATH).
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gyecology, AKH | Vienna | State of Vienna | 1090 | Austria |
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| Placebo | Other | control group would receive a oral lactose placebo |
|
| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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