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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Completed
• CT.gov ID: NCT01708148
• Collaborator: University of Natural Resources and Life Sciences, Vienna, Austria (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Reduction or Absence of Lactobacilli in Neovaginal Flora	Dietary Supplement: Probiotics; Other: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Other Outcome Measures

1. Nugent Score [day 0 day 7 of oral probiotic application]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Associate Prof. Ljubomir Petricevic MD, Ass. Prof MD, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT01708148
• Other Study ID Numbers: MUW EK982/2010
• First Posted: Oct 16, 2012
• Last Update Posted: Dec 6, 2016
• Last Verified: Dec 1, 2016

Study Results

No Results Posted as of Dec 6, 2016