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

29 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Probiotic Intervention for vaginal infections?

Research shows that certain probiotics, like Lactobacillus rhamnosus and Lactobacillus reuteri, can improve vaginal health by enhancing the balance of good bacteria and reducing harmful bacteria, which suggests that similar probiotics in the Probiotic Intervention might also be effective. ^{1 2 3 4 5}

Is it safe to use probiotics for vaginal health?

Research shows that probiotics like Lactobacillus acidophilus and Lactobacillus rhamnosus are generally safe for use in humans, with no severe adverse events reported in studies. They are well tolerated and can help maintain a healthy vaginal environment without causing unwanted changes. ^{1 3 6 7 8}

How is the probiotic treatment for vaginal infections unique?

This probiotic treatment is unique because it uses specific strains of beneficial bacteria, Lactobacillus acidophilus GLA-14 and Lactobacillus rhamnosus HN001, which are taken orally to help restore and maintain a healthy balance of bacteria in the vagina, potentially preventing infections. Unlike traditional treatments that may involve antifungal or antibacterial medications, this approach focuses on enhancing the body's natural defenses by promoting beneficial bacteria. ^{1 3 4 5 9}

What is the purpose of this trial?

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.

Research Team

Rupak Shivakoti, PhD

Principal Investigator

Columbia University Assistant Professor

Asa Radix, MD, PhD

Principal Investigator

Columbia University Associate Professor

Eligibility Criteria

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

I have not gone through menopause.

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Improved treatment of vulvovaginal candidiasis with fluconazole plus probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of a 10-Strain Oral Probiotic on Parameters of Vaginal Health and Microbial Community: A Pilot Clinical Study. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, placebo-controlled study of oral lactobacilli to improve the vaginal flora of postmenopausal women. [2022]

4. England 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. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Lactobacillus fermentum ATCC 23271 Displays In vitro Inhibitory Activities against Candida spp. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Healthy Vaginal Microbiota Remains Stable during Oral Probiotic Supplementation: A Randomised Controlled Trial. [2023]

7. United States 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. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Intravaginal administration of gelatine capsules containing freeze-dried autochthonous lactobacilli: a double-blind, randomised clinical trial of safety. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Study on the effects of an oral lactobacilli and lactoferrin complex in women with intermediate vaginal microbiota. [2022]