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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Reduction or Absence of Lactobacilli in Neovaginal Flora

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lactobacilli

30 Participants with verum

Group Type ACTIVE_COMPARATOR

Probiotics

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

30 Participants

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

control group would receive a oral lactose placebo

Interventions

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Probiotics

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

control group would receive a oral lactose placebo

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes