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

120 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Prebiotic + Probiotic Supplement for Vaginal Infections?

Research shows that probiotics, like Lactobacillus strains, can help improve vaginal health and are effective in treating and preventing urogenital infections in women. Studies have found that these probiotics can be used alongside traditional treatments to enhance their effectiveness. ^{1 2 3 4 5}

Is the Prebiotic + Probiotic Supplement safe for humans?

Studies show that probiotic supplements, including those with lactobacilli, are generally safe for humans. No severe adverse events were detected in trials, and they were well tolerated by participants. ^{1 2 6 7 8}

How does the Prebiotic + Probiotic Supplement treatment for vaginal infections differ from other treatments?

This treatment is unique because it combines prebiotics and probiotics to support the growth of beneficial bacteria in the vagina, potentially restoring balance without the side effects of traditional drugs. Unlike standard treatments, it can be taken orally and may be used alongside antibiotics or antifungal agents to enhance vaginal health. ^{2 9 10 11 12}

What is the purpose of this trial?

This virtual randomized controlled trial evaluates the efficacy of a prebiotic and probiotic supplement in providing relief from symptoms associated with bacterial vaginosis and yeast infections. Participants will be randomized into three groups-test product, active placebo, and excipient placebo-and will take two capsules daily for 30 days. The study will assess the effects on vaginal microbiome, symptoms of bacterial vaginosis and yeast infections, and overall vaginal health.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Probiotic and prebiotic applications for vaginal health. [2019]

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. United States pubmed.ncbi.nlm.nih.gov

Probiotics for Treatment and Prevention of Urogenital Infections in Women: A Systematic Review. [2018]

5. 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]

6. Denmark pubmed.ncbi.nlm.nih.gov

Vaginal microbiome following orally administered probiotic. [2022]

7. 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]

8. Switzerland pubmed.ncbi.nlm.nih.gov

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

Oral Intake of the Commercial Probiotic Blend Synbio® for the Management of Vaginal Dysbiosis. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Biotherapeutic agents and vaginal health. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Could probiotics be an option for treating and preventing urogenital infections? [2007]

12. Germany pubmed.ncbi.nlm.nih.gov

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