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

This study has been completed.
Sponsor:
Collaborator:
University of Natural Resources and Life Sciences, Vienna, Austria
Information provided by (Responsible Party):
Assistant Prof. Ljubomir Petricevic MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01708148
First received: October 11, 2012
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Reduction or Absence of Lactobacilli in Neovaginal Flora
Dietary Supplement: Probiotics
Other: Placebo

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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • change in Nugent score between baseline and end of treatment (improvement or no improvement). [ Time Frame: day 0 day 7 of oral probiotic application ] [ Designated as safety issue: No ]
    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:
  • Isolation of specific Lactobacilli from neovaginal microbiologic cultures after oral administration of probiotic [ Time Frame: Day 7 of oral probiotic application ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Nugent Score [ Time Frame: day 0 day 7 of oral probiotic application ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2011
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708148

Locations
Austria
Department of Obstetrics and Gyecology, AKH
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
University of Natural Resources and Life Sciences, Vienna, Austria
  More Information

No publications provided

Responsible Party: Assistant Prof. Ljubomir Petricevic MD, Ass. Prof MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01708148     History of Changes
Other Study ID Numbers: MUW EK982/2010
Study First Received: October 11, 2012
Last Updated: May 6, 2014
Health Authority: Austria: Agency for Health and Food Safety

ClinicalTrials.gov processed this record on July 24, 2014