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

Not Applicable

Completed

• Conditions: Reduction or Absence of Lactobacilli in Neovaginal Flora
• Interventions: Dietary Supplement: Probiotics; Other: Placebo

• Registration Number: NCT01708148
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2012-03
• Study First Submitted: 2012-10-11
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Study Completion: 2014-05
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lactobacilli	Probiotics	30 Participants with verum
Placebo	Placebo	30 Participants

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Obstetrics and Gyecology, AKH; 🇦🇹 Vienna, Austria