Vaginal DysbiosisTEST-FNCT06470906
Feasibility of an Oral Intervention for Sexual Health in Transgender Men
A study testing Probiotic Group in people with Vaginal Dysbiosis and Vaginal Disease, run by Columbia University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Dysbiosis, Vaginal Disease, Molecular-bacterial Vaginosis
- What is being tested?
- Probiotic Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to 21 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Callen-Lorde Community Health Center (CLCHC)
Brooklyn, New York, 11201
About this study
Official title: Testosterone Effects on Sexual Health in Transgender Men: Feasibility Study of an Oral Intervention
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.
Read the detailed description
Transgender men (TGM) have a higher risk of sexually transmitted infections (STIs) associated with vaginal dysbiosis, such as HIV, HPV and bacterial N. gonorrhea and C. trachomatis compared to cisgender women (CGW). TGM on testosterone therapy (TT) also have increased vaginal symptoms. Vaginal dysbiosis can be characterized as clinical-BV or molecular-BV (i.e. based on vaginal microbiota profile). Both are known contributors to increased vaginal symptoms and STI risk in CGW. Low Lactobacillus (LL) levels determine molecular-BV and clinical-BV. Studies show that TGM on TT show that they have a primarily LL vaginal microbiota. The investigators are planning a future study to test the efficacy of an oral Lactobacillus probiotic to improve vaginal health.
The goal for the future study is to test an intervention that the investigators hypothesize may be able to ameliorate some of the adverse health outcomes observed in TGM on TT. Thus, the investigators propose to use an intervention of a mixture of two components: 1) the probiotic Lactobacillus acidophilus GLA14 and 2) the probiotic Lactobacillus rhamnosus HN001. Studies have shown that an oral combination of this intervention increases vaginal Lactobacillus levels and improves vaginal health in CGW. The future study will test whether this intervention is effective in TGM on TT. This specific study is a pilot study to be conducted prior to the future study detailed above. Here, the investigators will randomize 30 TGM on TT to receive the intervention or placebo for 4 weeks. The intervention in the pilot study will be the same as the intervention of the main trial and will consist of the probiotics 1) Lactobacillus acidophilus GLA-14 and 2) Lactobacillus rhamnosus HN001. The placebo will be maltodextrin, the same as the proposed larger study. The investigators will assess the effect of the intervention on clinical-BV, molecular-BV (based on vaginal microbiota) and other clinical outcomes. Further, the investigators will determine the feasibility, acceptability, and adherence of the intervention. The investigators will conduct the pilot study at the CLCHC Brooklyn site. This pilot study will allow us to generate preliminary data, determine the feasibility and acceptability, and plan appropriately for the future study.
- Being tested
- Probiotic Group, Placebo Group
- Keywords
- Transgender men, Feasibility, Vaginal symptoms
- Medical subject headings
- Vaginal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic GroupDietary 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.
Placebo GroupDietary supplement
The placebo will of be Maltodextrin, a carbohydrate, packaged similarly to the intervention and having the same weight.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Intervention | Experimental | Participants will take one dose every day with water, for 4 weeks. Receives: Dietary Supplement: Probiotic Group |
| Placebo | Placebo comparator | Participants will take one dose every day with water, for 4 weeks. Receives: Dietary Supplement: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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:
- Among participants who are eligible, those who agree to receive the intervention
- Proportion of participants who successfully take the intervention through the study period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start14 Aug 2024
- Primary completion21 Nov 2024
- Study completion21 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DysbiosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 30 TGM on TT will be recruited and randomized them to take the intervention (n=15) or placebo (n=15).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Callen-Lorde Community Health Center
- Responsible party
- Principal investigator, Rupak Shivakoti, Columbia University
- Investigators
- Rupak Shivakoti, PhD, Principal investigator, Columbia University Assistant ProfessorAsa Radix, MD, PhD, Principal investigator, Columbia University Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470906
- Sponsor's protocol ID
- AAAV0602
- Acronym
- TEST-F
- Status last verified
- May 2025
- First submitted
- 13 Jun 2024
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone Effects on Sexual Health in Transgender Men: Feasibility Study of an Oral Intervention
- ClinicalTrials.gov ID
- NCT06470906
- Acronym / sponsor ID
- TEST-F / AAAV0602
- Keywords
- Transgender men, Feasibility, Vaginal symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Callen-Lorde Community Health Center
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 21 Nov 2024 (actual)
- Study completion
- 21 Nov 2024 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Transgender men (TGM) have a higher risk of sexually transmitted infections (STIs) associated with vaginal dysbiosis, such as HIV, HPV and bacterial N. gonorrhea and C. trachomatis compared to cisgender women (CGW). TGM on testosterone therapy (TT) also have increased vaginal symptoms. Vaginal dysbiosis can be characterized as clinical-BV or molecular-BV (i.e. based on vaginal microbiota profile). Both are known contributors to increased vaginal symptoms and STI risk in CGW. Low Lactobacillus (LL) levels determine molecular-BV and clinical-BV. Studies show that TGM on TT show that they have a primarily LL vaginal microbiota. The investigators are planning a future study to test the efficacy of an oral Lactobacillus probiotic to improve vaginal health.
The goal for the future study is to test an intervention that the investigators hypothesize may be able to ameliorate some of the adverse health outcomes observed in TGM on TT. Thus, the investigators propose to use an intervention of a mixture of two components: 1) the probiotic Lactobacillus acidophilus GLA14 and 2) the probiotic Lactobacillus rhamnosus HN001. Studies have shown that an oral combination of this intervention increases vaginal Lactobacillus levels and improves vaginal health in CGW. The future study will test whether this intervention is effective in TGM on TT. This specific study is a pilot study to be conducted prior to the future study detailed above. Here, the investigators will randomize 30 TGM on TT to receive the intervention or placebo for 4 weeks. The intervention in the pilot study will be the same as the intervention of the main trial and will consist of the probiotics 1) Lactobacillus acidophilus GLA-14 and 2) Lactobacillus rhamnosus HN001. The placebo will be maltodextrin, the same as the proposed larger study. The investigators will assess the effect of the intervention on clinical-BV, molecular-BV (based on vaginal microbiota) and other clinical outcomes. Further, the investigators will determine the feasibility, acceptability, and adherence of the intervention. The investigators will conduct the pilot study at the CLCHC Brooklyn site. This pilot study will allow us to generate preliminary data, determine the feasibility and acceptability, and plan appropriately for the future study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 30 TGM on TT will be recruited and randomized them to take the intervention (n=15) or placebo (n=15).
| Arm | Type | Receives |
|---|---|---|
| Probiotic Intervention | Experimental | Dietary Supplement: Probiotic GroupParticipants will take one dose every day with water, for 4 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo GroupParticipants will take one dose every day with water, for 4 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic GroupThe 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 | Probiotic Intervention |
| Placebo GroupThe placebo will of be Maltodextrin, a carbohydrate, packaged similarly to the intervention and having the same weight. | Dietary supplement | Placebo |
Primary outcome
Effect of the probiotic intervention on molecular-BV
Time frame: 4 weeks
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.
Effect of the probiotic intervention on clinical-BV
Time frame: 4 weeks
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.
6 secondary outcomes
Adherence of the probiotic intervention
Time frame: 4 weeks
Feasibility of the probiotic intervention
Time frame: 4 weeks
Acceptability of the probiotic intervention
Time frame: 4 weeks
Effect of the probiotic intervention on vaginal symptoms
Time frame: 4 weeks
Digestive tolerability of the probiotic among TGM on TT
Time frame: 4 weeks
Incidence of Adverse Events among TGM on TT
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rupak Shivakoti, PhD principal investigator
Columbia University Assistant Professor
Asa Radix, MD, PhD principal investigator
Columbia University Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Group in people with Vaginal Dysbiosis and Vaginal Disease, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the probiotic intervention on molecular-BV (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.