Probiotics for Vaginal Infections

(TEST-F Trial)

Overseen By Rupak Shivakoti, PhD

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Columbia University

Must be taking: Testosterone therapy

Must not be taking: Antibiotics, Antifungals, Immunosuppressives, others

Disqualifiers: HIV, Pregnancy, Severe illness, others

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if probiotics (beneficial bacteria) can improve vaginal health for transgender men undergoing testosterone therapy. Testosterone may cause vaginal dryness and other issues, and the study seeks to discover if probiotics can help. Participants will take either probiotics (Lactobacillus acidophilus GLA-14 and Lactobacillus rhamnosus HN001) or a placebo pill (Maltodextrin) daily for four weeks. Suitable candidates have a vagina and ovaries, are on testosterone therapy, and are willing to share personal health information. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on improving transgender health.

Will I have to stop taking my current medications?

The trial requires that you stop taking any non-study probiotics, intravaginal products, immunomodulatory or immunosuppressive drugs, and antibiotics or antifungals if used for more than 14 days. If you are on these medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that probiotics like Lactobacillus acidophilus and Lactobacillus rhamnosus HN001 are generally safe for use. Many individuals use them to support vaginal health and address issues like bacterial vaginosis, a type of vaginal irritation. Studies have found that these probiotics can help balance vaginal bacteria and may reduce infection symptoms.

These probiotics are usually well-tolerated, with previous studies reporting no serious side effects. Most people do not experience side effects, but if they occur, they are typically mild, such as gas or bloating. Overall, evidence suggests that taking these probiotics is safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using probiotics for vaginal infections because they offer a natural alternative to the typical treatments, which often include antibiotics. Unlike antibiotics that can disrupt the balance of bacteria and lead to resistance, probiotics aim to restore and maintain a healthy vaginal microbiome. This approach not only helps in treating infections but also supports the body's natural defense systems, potentially reducing recurrence rates. Additionally, probiotics are administered orally, making them easy to incorporate into daily routines without the side effects often associated with conventional medications.

What evidence suggests that this trial's treatments could be effective for improving vaginal health in transgender men on testosterone therapy?

This trial will compare a Probiotic Intervention with a Placebo for vaginal infections. Research has shown that probiotics, particularly Lactobacillus acidophilus and Lactobacillus rhamnosus, can improve vaginal health. These probiotics alter the bacterial balance in the vagina, helping to prevent infections such as bacterial vaginosis (BV). In one study, 83% of women who took these probiotics no longer had BV after treatment. Additionally, these probiotics work together to combat harmful bacteria, potentially maintaining a balanced and healthy vaginal microbiome. ^{6 7 8 9 10}

Who Is on the Research Team?

Rupak Shivakoti, PhD

Principal Investigator

Columbia University Assistant Professor

Asa Radix, MD, PhD

Principal Investigator

Columbia University Associate Professor

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Stated willingness to join a randomized trial study, follow procedures, and answer questions about personal medical and sexual history

I have not gone through menopause.

I have both ovaries and a vagina.

Exclusion Criteria

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

Known allergic reactions to components of the intervention or placebo

Are pregnant or planning to be pregnant during the study period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either the Lactobacillus probiotic intervention or placebo for 4 weeks

4 weeks

Weekly visits (in-person or virtual) for monitoring and adherence checks

Follow-up

Participants are monitored for safety, effectiveness, and adherence after the treatment phase

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo Group
• Probiotic Group

Trial Overview 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.

How Is the Trial Designed?

Group I: Probiotic Intervention Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Callen-Lorde Community Health Center

Collaborator

Trials

6

Recruited

5,600+

Published Research Related to This Trial

In a pilot study involving 43 healthy premenopausal women, a 10-strain probiotic formulation significantly reduced vaginal pH, indicating potential benefits for vaginal health, particularly in those with intermediate Nugent scores or elevated pH levels.

The probiotic was well tolerated with high compliance, and while it did not significantly change Nugent scores, it maintained lactobacilli abundance, suggesting a positive impact on vaginal microbiota.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 10-Strain Oral Probiotic on Parameters of Vaginal Health and Microbial Community: A Pilot Clinical Study. Martoni, CJ., Frederiksen, AKS., Damholt, A., et al.[2022]

A clinical trial demonstrated that an oral mixture of Lactobacillus acidophilus GLA-14 and Lactobacillus rhamnosus HN001, combined with bovine lactoferrin, significantly improved vaginal health by restoring normal Nugent scores in women with intermediate vaginal microbiota over 15 days.

The study confirmed that these probiotic strains can effectively colonize the vagina after oral ingestion, leading to a reduction in symptoms associated with abnormal vaginal microbiota, such as itching and discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study on the effects of an oral lactobacilli and lactoferrin complex in women with intermediate vaginal microbiota. Russo, R., Edu, A., De Seta, F.[2022]

Lactobacillus fermentum ATCC 23271 showed the best probiotic properties among various Lactobacillus species tested, demonstrating strong adhesion to mucin, co-aggregation with pathogens, and antimicrobial activity against Candida albicans, Neisseria gonorrhoeae, and Streptococcus agalactiae.

This strain effectively inhibited the binding of Candida albicans to mucin, suggesting it could be a valuable probiotic candidate to support treatment for vaginal candidiasis, especially given its ability to produce antimicrobial substances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lactobacillus fermentum ATCC 23271 Displays In vitro Inhibitory Activities against Candida spp. do Carmo, MS., Noronha, FM., Arruda, MO., et al.[2020]

In a study involving 40 adult women, daily oral consumption of the probiotic Lactobacillus paracasei LPC-S01 for 4 weeks showed a reduction in the harmful Gardnerella spp. bacteria, which is associated with vaginal health.

Although Lactobacillus paracasei was only detected in two participants, the overall findings suggest that this probiotic may help maintain a healthy vaginal microbiota by promoting beneficial bacteria and reducing pathogenic ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of oral consumption of capsules containing Lactobacillus paracasei LPC-S01 on the vaginal microbiota of healthy adult women: a randomized, placebo-controlled, double-blind crossover study. Koirala, R., Gargari, G., Arioli, S., et al.[2022]

In a study of 72 postmenopausal women, those taking the probiotics Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 showed a significant improvement in vaginal flora, with 60% achieving a reduction in Nugent scores by at least two grades compared to only 16% in the placebo group.

The median improvement in Nugent scores was 3 for the probiotic group versus 0 for the placebo group, indicating that these specific probiotic strains can effectively restore normal vaginal flora in postmenopausal women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, placebo-controlled study of oral lactobacilli to improve the vaginal flora of postmenopausal women. Petricevic, L., Unger, FM., Viernstein, H., et al.[2022]

Lactobacillus rhamnosus GR-1 and L. fermentum RC-14 were found to persist in the human vagina for up to 19 days after administration, indicating their potential effectiveness as urogenital probiotics.

In contrast, L. rhamnosus GG was only detectable for up to 5 days, suggesting that GR-1 and RC-14 may be better suited for vaginal colonization and treatment of urogenital infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistence of Lactobacillus fermentum RC-14 and Lactobacillus rhamnosus GR-1 but not L. rhamnosus GG in the human vagina as demonstrated by randomly amplified polymorphic DNA. Gardiner, GE., Heinemann, C., Bruce, AW., et al.[2019]

In a study involving 55 women with vulvovaginal candidiasis (VVC), the addition of probiotic lactobacilli to fluconazole treatment significantly reduced symptoms and yeast presence compared to a placebo group.

The probiotic group experienced only 10.3% of participants with vaginal discharge symptoms after 4 weeks, compared to 34.6% in the placebo group, indicating that probiotics can enhance the effectiveness of antifungal treatments for VVC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved treatment of vulvovaginal candidiasis with fluconazole plus probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14. Martinez, RC., Franceschini, SA., Patta, MC., et al.[2022]

In a study involving 50 healthy women, the probiotic strains Lactobacillus acidophilus La-14 and Lacticaseibacillus rhamnosus HN001 did not colonize the vagina above detectable levels, indicating limited effectiveness in this context.

Despite the lack of colonization, the vaginal microbiota remained stable and healthy throughout the study, with no adverse safety concerns or significant changes in immune markers, suggesting that the probiotics did not negatively impact vaginal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Healthy Vaginal Microbiota Remains Stable during Oral Probiotic Supplementation: A Randomised Controlled Trial. Lyra, A., Ala-Jaakkola, R., Yeung, N., et al.[2023]

A clinical trial involving healthy sexually active women showed that vaginal administration of lactobacilli (LAB) capsules was safe and well tolerated, with no severe adverse events reported.

The study indicated a significant increase in cultivable lactobacilli after treatment with LAB capsules, suggesting their potential effectiveness in restoring healthy vaginal microbiota and preventing urogenital infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravaginal administration of gelatine capsules containing freeze-dried autochthonous lactobacilli: a double-blind, randomised clinical trial of safety. De Gregorio, PR., Maldonado, NC., Pingitore, EV., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5806794/

Effects of Lactobacillus rhamnosus and ... Our results demonstrate that the Lactobacilli combination was synergic against E. coli, demonstrating that the association of two probiotic strains can be ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1471489221001442

Does probiotics work for bacterial vaginosis and ... The results proved a remarkable improvement of the vaginal microbiome as 83% of the women in the test group were absolutely free of BV after the therapy period ...

3. mdpi.com mdpi.com/2072-6643/9/6/531

Lactobacillus rhamnosus HN001 and ... These results suggest that orally administered probiotics may ameliorate BV by colonizing the vagina. However, there are few studies on the relationship between ...

4. frontiersin.org frontiersin.org/journals/cellular-and-infection-microbiology/articles/10.3389/fcimb.2023.1153894/full

Use of probiotic lactobacilli in the treatment of vaginal ... Furthermore, probiotic lactobacilli have been found to be effective in changing the vaginal microbiota and improving individual health (López-Moreno and ...

5. cureus.com cureus.com/articles/47099-live-bacteria-supplementation-as-probiotic-for-managing-fishy-odorous-vaginal-discharge-disease-of-bacterial-vaginosis-an-alternative-treatment-option

Live Bacteria Supplementation as Probiotic for Managing ... Many earlier research pieces have proved the efficacy of probiotic supplementation in treating various vaginal infections like BV and ...

6. mayoclinic.org mayoclinic.org/drugs-supplements-acidophilus/art-20361967

Acidophilus People often take acidophilus to treat a type of vaginal inflammation, called bacterial vaginosis, and digestive disorders. They also may take it to boost ...

7. webmd.com webmd.com/vitamins/ai/ingredientmono-790/lactobacillus-acidophilus

Lactobacillus Acidophilus - Uses, Side Effects, And More Lactobacillus acidophilus (L. acidophilus) is a type of probiotic ("good" bacteria) found in the human gut, mouth, and vagina, and also in certain foods.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5490510/

Lactobacillus rhamnosus HN001 and ... Our study suggests that L1, L2, and PM attenuated GV-induced vaginosis by regulating both vaginal and systemic innate and adaptive immune responses.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06665126

A Study to Evaluate the Effects of a Prebiotic and Probiotic ... The study will assess the effects on vaginal microbiome, symptoms of bacterial vaginosis and yeast infections, and overall vaginal health. Official Title. A ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9366906/

The role of probiotics in vaginal health - PMC - PubMed Central Lactobacillus rhamnosus HN001 and lactobacillus acidophilus la-14 attenuate gardnerella vaginalis-infected bacterial vaginosis in mice.