Completed

NCT Number: NCT01708148

Oral Administration of Four Lactobacillus Species Preparation to Improve the Quality of the Neovaginal Flora in Male to Female Transsexual Patients

The aim of this study is the improvement of the penile linked neovaginal flora in male-to-female transsexuals after application of oral probiotics.

Completed

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Key information

Conditions

Reduction or Absence of Lactobacilli in Neovaginal Flora

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gyecology, AKH

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotics

Dietary Supplement

lyophilised L. rhamnosus, L. jensenii, L. crispatus, L. gasseri and sodium alginate

Placebo

Other

control group would receive a oral lactose placebo

Primary outcomes

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)

Secondary outcomes

Isolation of specific Lactobacilli from neovaginal microbiologic cultures after oral administration of probiotic

Time frame: Day 7 of oral probiotic application

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 outcomes

Nugent Score

Time frame: day 0 day 7 of oral probiotic application

Sponsors and collaborators

Lead sponsor

Medical University of Vienna