Feasibility of an Oral Intervention for Sexual Health in Transgender Men

Summary

Transgender men (TGM) have a high incidence of sexually transmitted infected (STIs), including HIV, HPV and bacterial N. gonorrhea and C. trachomatis. In addition, TGM who start testosterone therapy (TT) experience significant vaginal morbidity that causes vaginal dryness and pain, due to the estrogen-inhibiting effects of TT on vaginal epithelium. Vaginal dysbiosis is a known contributor of increased STI risk and vaginal symptoms. In a future study, the investigators are planning a randomized trial of a 6-month oral Lactobacillus probiotics intervention in TGM on TT at the Callen-Lorde Community Health Center (CLCHC), New York City to determine whether this intervention can improve vaginal health in TGM on TT. In this study, the investigators will conduct a pilot and feasibility study to precede the main trial. The investigators will randomize 30 TGM on TT to receive either the intervention (consisting of Lactobacillus acidophilus GLA-14 and Lactobacillus rhamnosus HN001) or placebo (maltodextrin) for 4 weeks, evaluating the intervention's impact on vaginal microbiota and clinical outcomes, as well as its feasibility, acceptability, and adherence. This study will take place at the CLCHC Brooklyn site, aiming to gain pilot data, address feasibility and acceptability, and plan for the main trial accordingly.

Conditions

• Vaginal Dysbiosis
• Vaginal Disease
• Molecular-bacterial Vaginosis

Interventions

DIETARY_SUPPLEMENT

Probiotic Group

The intervention is a mixture of two probiotics: 1) Lactobacillus acidophilus GLA-14 and 2) Lactobacillus rhamnosus HN001. These products will be combined into a single capsule/sachet with a dose of approximately 10\^10 colony forming units (CFUs) of GLA-14 (ATCC SD5212) and HN001 (ATCC SD5675) in a 4:1 ratio, using similar doses as recent studies using this product.

DIETARY_SUPPLEMENT

Placebo Group

The placebo will of be Maltodextrin, a carbohydrate, packaged similarly to the intervention and having the same weight.

Sponsors & Collaborators

• Callen-Lorde Community Health Center

  collaborator OTHER

• Columbia University

  lead OTHER

Principal Investigators

• Rupak Shivakoti, PhD · Columbia University Assistant Professor

• Asa Radix, MD, PhD · Columbia University Associate Professor

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-08-14

Primary Completion

2024-11-21

Completion

2024-11-21

Countries

• United States

Study Locations