Reduction or Absence of Lactobacilli in Neovaginal FloraNCT01708148
Oral Administration of Four Lactobacillus Species Preparation to Improve the Quality of the Neovaginal Flora in Male to Female Transsexual Patients
A study testing Probiotics in people with Reduction or Absence of Lactobacilli in Neovaginal Flora, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reduction or Absence of Lactobacilli in Neovaginal Flora
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2011to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Obstetrics and Gyecology, AKH
Vienna, State of Vienna, 1090
About this study
The aim of this study is the improvement of the penile linked neovaginal flora in male-to-female transsexuals after application of oral probiotics.
- Being tested
- Probiotics, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
lyophilised L. rhamnosus, L. jensenii, L. crispatus, L. gasseri and sodium alginate
PlaceboOther
control group would receive a oral lactose placebo
| Study group | Role | What they receive |
|---|---|---|
| Lactobacilli | Active comparator | 30 Participants with verum Receives: Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | 30 Participants Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: day 0 day 7 of oral probiotic application
Secondary outcomes (1)
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.
Measured: Day 7 of oral probiotic application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startSep 2011
- Primary completionMar 2012
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduction or Absence of Lactobacilli in Neovaginal FloraStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Natural Resources and Life Sciences, Vienna, Austria
- Responsible party
- Principal investigator, Associate Prof. Ljubomir Petricevic MD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708148
- Sponsor's protocol ID
- MUW EK982/2010
- Status last verified
- Dec 2016
- First submitted
- 11 Oct 2012
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Administration of Four Lactobacillus Species Preparation to Improve the Quality of the Neovaginal Flora in Male to Female Transsexual Patients
- ClinicalTrials.gov ID
- NCT01708148
- Acronym / sponsor ID
- MUW EK982/2010
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- University of Natural Resources and Life Sciences, Vienna, Austria
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is the improvement of the penile linked neovaginal flora in male-to-female transsexuals after application of oral probiotics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacilli | Active comparator | Dietary Supplement: Probiotics30 Participants with verum |
| Placebo | Placebo comparator | Other: Placebo30 Participants |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (8 listed)
- clinical signs of vaginal or urinary tract infection,
- abnormal neovaginal discharge,
- neoplasia,
- bleeding,
- diarrhoea,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probioticslyophilised L. rhamnosus, L. jensenii, L. crispatus, L. gasseri and sodium alginate | Dietary supplement | Lactobacilli |
| Placebocontrol group would receive a oral lactose placebo | Other | Placebo |
Primary outcome
change in Nugent score between baseline and end of treatment (improvement or no improvement).
Time frame: day 0 day 7 of oral probiotic application
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)
1 secondary outcome
Isolation of specific Lactobacilli from neovaginal microbiologic cultures after oral administration of probiotic
Time frame: Day 7 of oral probiotic application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Reduction or Absence of Lactobacilli in Neovaginal Flora, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Nugent score between baseline and end of treatment (improvement or no improvement). (time frame: day 0 day 7 of oral probiotic application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.