Feasibility of an Oral Intervention for Sexual Health in Transgender Men

NCT06470906 | Completed

• 1 other identifier: AAAV0602
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Transgender men; Feasibility; Vaginal symptoms

Outcome Measures

Primary Outcomes (2)

• Effect of the probiotic intervention on molecular-BV

  The investigators aim to determine the effect of the Lactobacillus-probiotic intervention on molecular-BV through assessing Lactobacillus and other bacteria in the participants vaginal microbiome at the end of the intervention in TGM on TT.

  4 weeks

• Effect of the probiotic intervention on clinical-BV

  The investigators aim to determine the effect of the Lactobacillus-probiotic intervention on clinical-BV (by Nugent score) at the end of the intervention in TGM on TT. Using Nugent score, a score of 0-3 is considered negative for BV, 4-6 is considered indeterminate for bacterial vaginosis, 7+ is considered indicative of BV.

  4 weeks

Secondary Outcomes (6)

• Adherence of the probiotic intervention

  4 weeks

• Feasibility of the probiotic intervention

  4 weeks

• Acceptability of the probiotic intervention

  4 weeks

• Effect of the probiotic intervention on vaginal symptoms

  4 weeks

• Digestive tolerability of the probiotic among TGM on TT

  4 weeks

Study Arms (2)

Probiotic Intervention

EXPERIMENTAL

Participants will take one dose every day with water, for 4 weeks.

Dietary Supplement: Probiotic Group

Placebo

PLACEBO COMPARATOR

Participants will take one dose every day with water, for 4 weeks.

Dietary Supplement: Placebo Group

Interventions

Probiotic Group DIETARY_SUPPLEMENT

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.

Probiotic Intervention

Placebo Group DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity. Individuals who were assigned female at birth and self-identity as TGM, male, transmasculine or nonbinary will be enrolled.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• Callen-Lorde Community Health Center: collaborator

Study Sites (1)

Callen-Lorde Community Health Center (CLCHC)

Brooklyn, New York, 11201, United States

Location

MeSH Terms

Conditions

Vaginal Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Rupak Shivakoti, PhD

  Columbia University Assistant Professor

  PRINCIPAL INVESTIGATOR

• Asa Radix, MD, PhD

  Columbia University Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Phase 2 participants will be randomized at a 1:1 ratio (intervention: placebo) using a permuted block design. Concealment of random assignment will be accomplished by creation of randomized treatment assignment list, based on permuted block size, by a statistician/data manager at Columbia University who is not part of the investigative team. This statistician/data manager will hold the key to the treatment assignment and will also 1) communicate with the manufacturer on the labeling of sachets, 2) provide the random assignment list to the study site (which will lack information on treatment assignment or block size). In addition, the intervention and placebo will use identical packaging and labeling, and the placebo will have the same amount and similar taste/appearance as the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Epidemiology

Model Details: 30 TGM on TT will be recruited and randomized them to take the intervention (n=15) or placebo (n=15).

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 24, 2024
• Study Start: August 14, 2024
• Primary Completion: November 21, 2024
• Study Completion: November 21, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)