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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01708148

Enrollment

Registered

2012-10-16

Start date

2011-09-30

Completion date

2014-05-31

Last updated

2016-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reduction or Absence of Lactobacilli in Neovaginal Flora

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.

Interventions

DIETARY_SUPPLEMENTProbiotics

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

OTHERPlacebo

control group would receive a oral lactose placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
change in Nugent score between baseline and end of treatment (improvement or no improvement).	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

Measure	Time frame	Description
Isolation of specific Lactobacilli from neovaginal microbiologic cultures after oral administration of probiotic	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

Measure	Time frame
Nugent Score	day 0 day 7 of oral probiotic application

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026