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

Medical University of Vienna

Status: Completed

Conditions: Reduction or Absence of Lactobacilli in Neovaginal Flora

Treatments: Other: Placebo; Dietary Supplement: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT01708148

MUW EK982/2010

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Lactobacilli

Active Comparator group

Description:

30 Participants with verum

Treatment:

Dietary Supplement: Probiotics

Placebo

Placebo Comparator group

Description:

30 Participants

Treatment:

Other: Placebo