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

Reduction or Absence of Lactobacilli in Neovaginal Flora Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708148
• Other study ID #: MUW EK982/2010
• Status: Completed
• Phase: N/A
• First received: October 11, 2012
• Last updated: December 5, 2016
• Start date: September 2011
• Est. completion date: May 2014

Study information

• Verified date: December 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2014
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Reduction or Absence of Lactobacilli in Neovaginal Flora

Intervention

Dietary Supplement:
• Probiotics
lyophilised L. rhamnosus, L. jensenii, L. crispatus, L. gasseri and sodium alginate

Other:
• Placebo
control group would receive a oral lactose placebo

Locations

Country	Name	City	State
Austria	Department of Obstetrics and Gyecology, AKH	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	University of Natural Resources and Life Sciences, Vienna, Austria

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nugent Score		day 0 day 7 of oral probiotic application	No
Primary	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	No
Secondary	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	No