MedDataX Logo

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

NCT ID: NCT01708148

Last Updated: 2016-12-06

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Reduction or Absence of Lactobacilli in Neovaginal Flora

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Natural Resources and Life Sciences, Vienna, Austria

OTHER

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Associate Prof. Ljubomir Petricevic MD

Ass. Prof MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Obstetrics and Gyecology, AKH

Vienna, Vienna, Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MUW EK982/2010

Identifier Type: -

Identifier Source: org_study_id