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.

Study Overview

• Status: Completed
• Conditions: Reduction or Absence of Lactobacilli in Neovaginal Flora
• Intervention / Treatment: Dietary supplement: Probiotics; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Obstetrics and Gyecology, AKH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lactobacilli; 30 Participants with verum	Dietary supplement: Probiotics; lyophilised L. rhamnosus, L. jensenii, L. crispatus, L. gasseri and sodium alginate
Placebo Comparator: Placebo; 30 Participants	Other: Placebo; control group would receive a oral lactose placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	day 0 day 7 of oral probiotic application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 7 of oral probiotic application

Other Outcome Measures

Outcome Measure	Time Frame
Nugent Score	day 0 day 7 of oral probiotic application

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: University of Natural Resources and Life Sciences, Vienna, Austria

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: October 11, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Estimate): December 6, 2016
• Last Update Submitted That Met QC Criteria: December 5, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: MUW EK982/2010