Feasibility of an Oral Intervention for Sexual Health in Transgender Men
NCT Number: NCT06470906
Acronym: TEST-F
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vaginal Dysbiosis|Vaginal Disease|Molecular-bacterial Vaginosis
Interventions: DIETARY_SUPPLEMENT: Probiotic Group|DIETARY_SUPPLEMENT: Placebo Group
Sponsor: Columbia University
Collaborators: Callen-Lorde Community Health Center
Sex: MALE
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-14
Completion Date: 2025-07
Locations: Callen-Lorde Community Health Center (CLCHC), Brooklyn, New York, 11201, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Adherence of the probiotic intervention, The investigators will examine the adherence of the probiotic intervention given to TGM on TT by analyzing the number of intervention doses administered and the number of doses returned, unused, at the end of the study., 4 weeks|Feasibility of the probiotic intervention, The investigators will evaluate feasibility by determining if at least 75% of participants report successfully taking the intervention., 4 weeks|Acceptability of the probiotic intervention, The investigators will examine the acceptability of the probiotic intervention given to TGM on TT by assessing two indicators:

1. Among participants who are eligible, those who agree to receive the intervention
2. Proportion of participants who successfully take the intervention through the study period., 4 weeks|Effect of the probiotic intervention on vaginal symptoms, The investigators aim to determine the effect of a Lactobacillus-probiotic intervention on vaginal symptoms (e.g., itching, odor, discharge, dryness, pain, irritation, burning or stinging) at the end of the intervention in TGM on TT. Presence of symptoms will be used to determine a composite binary variable for vaginal symptoms (yes/no).Each symptom, as a binary variable, also will further be explored., 4 weeks|Digestive tolerability of the probiotic among TGM on TT, The investigators aim to assess the digestive tolerability of the Lactobacillus-probiotic intervention including bloating, flatulence, and diarrhea. Tolerability will be used to determine a composite binary variable for tolerability (yes/no). Each category, as a binary variable, also will further be explored., 4 weeks|Incidence of Adverse Events among TGM on TT, The investigators aim to evaluate the safety of the Lactobacillus-probiotic intervention by monitoring and analyzing the incidence of adverse events., 4 weeks