Oral Administration of Four Lactobacillus Species Preparation to Improve the Quality of the Neovaginal Flora in Male to Female Transsexual Patients
1 other identifier
interventional
60
1 country
1
Brief Summary
The aim of this study is the improvement of the penile linked neovaginal flora in male-to-female transsexuals after application of oral probiotics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 11, 2012
CompletedFirst Posted
Study publicly available on registry
October 16, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedDecember 6, 2016
December 1, 2016
6 months
October 11, 2012
December 5, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Isolation of specific Lactobacilli from neovaginal microbiologic cultures after oral administration of probiotic
Day 7 of oral probiotic application
Other Outcomes (1)
Nugent Score
day 0 day 7 of oral probiotic application
Study Arms (2)
Lactobacilli
ACTIVE COMPARATOR30 Participants with verum
Placebo
PLACEBO COMPARATOR30 Participants
Interventions
lyophilised L. rhamnosus, L. jensenii, L. crispatus, L. gasseri and sodium alginate
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics and Gyecology, AKH
Vienna, Vienna, 1090, Austria
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ass. Prof MD
Study Record Dates
First Submitted
October 11, 2012
First Posted
October 16, 2012
Study Start
September 1, 2011
Primary Completion
March 1, 2012
Study Completion
May 1, 2014
Last Updated
December 6, 2016
Record last verified: 2016-12