CompletedNot Applicable

Feasibility of an Oral Intervention for Sexual Health in Transgender Men

United States29 participantsStarted 2024-08-14

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 18-45 years * Pre-menopausal * Assigned female at birth and self-identity as TGM, male, transmasculine or nonbinary * Presence of vagina and ovaries * Currently on TT * Stated willingness to join a randomized trial study, follow procedures, and answer questions about personal medical and sexual history Exclusion Criteria: * Gender-affirming genital surgery (including phalloplasty, metoidioplasty, vaginectomy, hysterectomy, oophorectomy), * Known allergic reactions to components of the intervention or placebo * Have known HIV infection or symptomatic gonorrhea or chlamydia * Are pregnant or planning to be pregnant during the study period * Are on puberty-blockers * Are currently taking or plan to take any non-study probiotics or any intravaginal product that may impact the outcomes of interest * Use immunomodulatory or immunosuppressive drugs or are currently taking antibiotics or antifungals for \>14 days * Have a severe illness (e.g., cancer, major psychiatric or neurological conditions), are planning to move away from the area during the study period, or have any condition that would make participation in the study unsafe (in the opinion of study staff) * Have any condition that would make participation in the study unsafe (in the opinion of study staff), complicate interpretation of study outcome data, or otherwise interfere with achieving the study aims.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effect of the probiotic intervention on molecular-BV

Timeframe: 4 weeks

Effect of the probiotic intervention on clinical-BV

Timeframe: 4 weeks

Trial details

NCT IDNCT06470906

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-21

View on ClinicalTrials.gov More Vaginal Dysbiosis trials