Prebiotic + Probiotic Supplement for Vaginal Infections

Overseen By Patrick Renner, MSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Happy V

Must not be taking: Vaginal health supplements

Disqualifiers: Oncological, Psychiatric, Pregnant, others

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a prebiotic and probiotic supplement to determine its effectiveness in alleviating symptoms of bacterial vaginosis and yeast infections, such as itchiness and unusual discharge. Participants will be divided into three groups: one taking the supplement, one taking an active placebo, and one taking a regular placebo. The trial will examine changes in the vaginal microbiome (natural bacterial environment) and overall vaginal health. Women experiencing ongoing symptoms like unpleasant odor and digestive discomfort, who are otherwise healthy, may be suitable for this study. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance future treatments.

Will I have to stop taking my current medications?

The trial requires you to avoid using any vaginal health-related medications, supplements, and herbal remedies during the study. If you are taking oral supplements or herbal remedies for vaginal health, you must have been on them for at least 3 months before the study and continue them throughout the study.

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

Research has shown that probiotics can maintain a healthy balance of bacteria in the vagina and may strengthen the body's defenses against infections. Studies have found that while probiotics might not always cure bacterial vaginosis, they can improve the bacterial mix in the vagina, creating a healthier environment overall.

Probiotics have also reduced the recurrence of bacterial vaginosis. They usually have few side effects, making them a well-tolerated choice for many people. Although the exact effects can vary, using prebiotic and probiotic supplements for vaginal health is generally considered safe based on past research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the prebiotic and probiotic supplement for vaginal infections because it offers a natural approach to restoring balance in the vaginal microbiome. Unlike traditional treatments, which often involve antibiotics that can disrupt beneficial bacteria, this supplement works by promoting the growth of healthy bacteria and enhancing the natural defense mechanisms of the body. This dual-action approach not only aims to treat infections but also helps prevent them from recurring, offering a more sustainable solution in maintaining vaginal health.

What evidence suggests that this trial's treatments could be effective for vaginal infections?

Research suggests that probiotics might help with bacterial vaginosis (BV) and yeast infections. Studies have found that probiotics can increase the chances of curing BV and reduce the likelihood of recurrence. They work by boosting the growth of healthy bacteria, like Lactobacilli, which are important for vaginal health. However, evidence for their effectiveness against yeast infections is less certain, with some studies showing no major benefits. This trial will evaluate a prebiotic and probiotic supplement, provided to participants in the test product group. Using prebiotics, which feed good bacteria, along with probiotics might enhance these effects by supporting a healthy balance of bacteria in the vagina. While these findings are promising, more research is needed for confirmation. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing symptoms of bacterial vaginosis or yeast infections. Participants will be taking two capsules daily for a month and must have access to the internet as it's a virtual study.

Inclusion Criteria

I am a woman aged 25 or older.

I agree not to use any vaginal health products during the study.

I experience bloating, gas, or other digestive discomfort.

Exclusion Criteria

I have not started any new vaginal health medications or supplements in the last 3 months.

Unwilling to follow the study protocol

Anyone with known severe allergic reactions that require the use of an Epi-Pen, or any known allergies to any of the product ingredients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants take two capsules daily for 30 days to evaluate the effects on vaginal microbiome and symptoms of bacterial vaginosis and yeast infections

4 weeks

Virtual assessments at Baseline, Day 1, Day 7, Day 14, Day 21, Day 30

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prebiotic + Probiotic Supplement

Trial Overview The study tests if a prebiotic and probiotic supplement can relieve symptoms associated with vaginal infections. It compares this test product to an active placebo and an excipient placebo in a randomized, controlled setup.

How Is the Trial Designed?

Group I: Test Product Group Experimental Treatment 1 Intervention

Participants in this group will receive the test product, a prebiotic and probiotic supplement.

Group II: Active Placebo Group Placebo Group 1 Intervention

Participants in this group will receive an active placebo.

Group III: Excipient Placebo Group Placebo Group 1 Intervention

Participants in this group will receive an excipient placebo.

Who Is Running the Clinical Trial?

Happy V

Lead Sponsor

Trials

1

Recruited

120+

Citruslabs

Industry Sponsor

Trials

94

Recruited

5,100+

Published Research Related to This Trial

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]

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]

Urogenital infections affect a significant number of women each year, yet they receive insufficient attention and funding for research and treatment options.

Probiotic therapy shows promise for improving women's health by replenishing beneficial microflora in the urogenital area, although specific strains for this purpose are still under development and not yet available commercially.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Could probiotics be an option for treating and preventing urogenital infections? Reid, G., Bruce, AW.[2007]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06665126

A Study to Evaluate the Effects of a Prebiotic and Probiotic ... A Study to Evaluate the Effects of a Prebiotic and Probiotic Supplement to Provide Relief From Symptoms Associated With Bacterial Vaginosis and Yeast Infections ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11111202/

The Role of Probiotics in the Treatment of Vulvovaginal ... The results showed that taking probiotics after taking antibiotics had no effect on the rate of Candida infection after antibiotic treatment (24).

3. sciencedirect.com sciencedirect.com/science/article/pii/S1028455923003017

The role of probiotics in women's health In gynecologic conditions, probiotics show potential in preventing and managing bacterial vaginosis, vulvovaginal candidiasis, and sexually transmitted ...

4. nature.com nature.com/articles/s41598-025-92843-7

Probiotics reduce the recurrence of asymptomatic bacterial ... Probiotics may increase the cure rate and reduce the recurrence rate of symptomatic bacterial vaginosis (sBV), while no study has compared the ...

5. asm.org asm.org/articles/2025/april/can-probiotics-transform-vaginal-microbiome

Can Probiotics Transform the Vaginal Microbiome? Overall, Lactobacilli and Bifidobacteria are indicators of a healthy vaginal microbiome, but there are limited data to support whether using ...

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

The role of probiotics in vaginal health - PMC - PubMed Central Supplementation with probiotics did not improve BV cure rates, but improved vaginal flora composition.

7. webmd.com webmd.com/women/vaginal-probiotics

Vaginal Probiotics: What to Know Probiotics may help maintain a stable vaginal microbiome and can boost immune defense against infections and disease.