Oral Administration of Four Lactobacillus Species Preparation to Improve the Quality of the Neovaginal Flora in Male to Female Transsexual Patients
This study has been completed.
Sponsor:
Medical University of Vienna
Collaborator:
University of Natural Resources and Life Sciences, Vienna, Austria
Information provided by (Responsible Party):
Assistant Prof. Ljubomir Petricevic MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01708148
First received: October 11, 2012
Last updated: October 15, 2012
Last verified: October 2012
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Purpose
The aim of this study is the improvement of the penile linked neovaginal flora in male-to-female transsexuals after application of oral probiotics.
| Condition | Intervention |
|---|---|
|
Reduction or Absence of Lactobacilli in Neovaginal Flora |
Dietary Supplement: Probiotics Other: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
Resource links provided by NLM:
Further study details as provided by Medical University of Vienna:
Primary Outcome Measures:
- change in Nugent score between baseline and end of treatment (improvement or no improvement). [ Time Frame: day 0 day 7 of oral probiotic application ] [ Designated as safety issue: No ]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)
Secondary Outcome Measures:
- Isolation of specific Lactobacilli from neovaginal microbiologic cultures after oral administration of probiotic [ Time Frame: Day 7 of oral probiotic application ] [ Designated as safety issue: No ]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.
Other Outcome Measures:
- Nugent Score [ Time Frame: day 0 day 7 of oral probiotic application ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | September 2011 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Lactobacilli
30 Participants with verum
|
Dietary Supplement: Probiotics
lyophilised L. rhamnosus, L. jensenii, L. crispatus, L. gasseri and sodium alginate
|
|
Placebo Comparator: Placebo
30 Participants
|
Other: Placebo
control group would receive a oral lactose placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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:
- clinical signs of vaginal or urinary tract infection,
- abnormal neovaginal discharge,
- neoplasia,
- bleeding,
- diarrhoea,
- constipation,
- rectal pathologies including hemorrhoids,
- antibiotic therapy in the previous 4 weeks
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Assistant Prof. Ljubomir Petricevic MD, Ass. Prof MD, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT01708148 History of Changes |
| Other Study ID Numbers: | MUW EK982/2010 |
| Study First Received: | October 11, 2012 |
| Last Updated: | October 15, 2012 |
| Health Authority: | Austria: Agency for Health and Food Safety |
ClinicalTrials.gov processed this record on May 16, 2013