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Placebo

Probiotics for Vaginal Infections (TEST-F Trial)

N/A
Recruiting
Led By Rupak Shivakoti, PhD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of vagina and ovaries
Pre-menopausal
Must not have
Gender-affirming genital surgery (including phalloplasty, metoidioplasty, vaginectomy, hysterectomy, oophorectomy)
Have known HIV infection or symptomatic gonorrhea or chlamydia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks

Summary

"This trial aims to study the effects of a 6-month oral Lactobacillus probiotics intervention in transgender men on testosterone therapy to improve vaginal health. The study will begin with a pilot and

Who is the study for?
This trial is for transgender men who are on testosterone therapy and experiencing vaginal health issues like dryness or pain. They should be interested in trying a probiotic to see if it helps with these symptoms and reduces the risk of sexually transmitted infections.
What is being tested?
The study tests whether taking Lactobacillus probiotics orally for four weeks can improve vaginal health in transgender men on testosterone therapy, compared to a placebo. It's a small-scale pilot study before a larger one, where participants are randomly assigned to either the probiotic or placebo group.
What are the potential side effects?
While specific side effects aren't listed, generally speaking, probiotics may cause digestive discomfort such as gas or bloating initially. Placebos typically have no active ingredients but can lead to perceived side effects due to expectations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have both ovaries and a vagina.
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I have not gone through menopause.
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I am currently on targeted therapy.
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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have undergone gender-affirming genital surgery.
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I have HIV or symptoms of gonorrhea or chlamydia.
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I am not currently using drugs that affect my immune system or taking long-term antibiotics or antifungals.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effect of the probiotic intervention on clinical-BV
Effect of the probiotic intervention on molecular-BV
Secondary study objectives
Acceptability of the probiotic intervention
Adherence of the probiotic intervention
Digestive tolerability of the probiotic among TGM on TT
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Probiotic InterventionExperimental Treatment1 Intervention
Participants will take one dose every day with water, for 4 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will take one dose every day with water, for 4 weeks.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,655,286 Total Patients Enrolled
Callen-Lorde Community Health CenterOTHER
4 Previous Clinical Trials
5,088 Total Patients Enrolled
Rupak Shivakoti, PhDPrincipal InvestigatorColumbia University Assistant Professor
1 Previous Clinical Trials
144 Total Patients Enrolled
~19 spots leftby May 2025
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