Vaginal Care System for Urinary Tract Infection

Overseen By Shanya San

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Vaginal Biome Science

Disqualifiers: Immunosuppressed, Allergies, Vaginal infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new vaginal hygiene system, called BioNourish, can reduce urinary tract infections (UTIs) in menopausal women by improving the balance of good bacteria in the vagina. The trial will compare two groups: one receiving routine care and another using the experimental system, which includes a wash, moisturizing gel, and probiotic suppository. Post-menopausal women who have experienced multiple UTIs in the past year might be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance women's health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that women with chronic conditions controlled by common medications can participate, so you may not need to stop them.

What prior data suggests that the BioNourish Vaginal Care System is safe for menopausal women?

Research shows that the Vaginal Care System, which includes probiotics like Lactobacillus strains, is generally safe. Studies on these probiotics have found that users usually tolerate them well.

The system includes a vulvar wash, a moisturizing gel called BioNourish, and a probiotic suppository, all designed to maintain a healthy vaginal environment. Although this specific trial lacks detailed safety data, similar probiotic systems have not shown serious side effects in other studies.

The treatment's availability over-the-counter, rather than in a trial phase, suggests a reasonable level of safety evidence. However, some users might experience mild reactions such as irritation. Always consult a healthcare provider if concerns arise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for urinary tract infections, which often rely on antibiotics, the BioNourish vaginal care system takes a different approach by focusing on restoring and maintaining a healthy vaginal environment. This system includes a vulvar wash, a specially formulated vaginal moisturizing gel, and a homeopathic suppository with probiotics. Researchers are excited about these treatments because they aim to support the natural balance of the vaginal microbiome, potentially reducing UTI recurrence by promoting healthy pH and lactic acid levels. This holistic method could offer a more sustainable and less invasive alternative to traditional antibiotic therapies.

What evidence suggests that the BioNourish Vaginal Care System is effective for reducing recurrent UTIs in menopausal women?

Research has shown that the vaginal microbiome, the community of healthy bacteria in the vagina, plays a crucial role in protecting against urinary tract infections (UTIs). In menopausal women, changes in this microbiome can increase UTI risk. Early findings suggest that products like probiotics, which restore bacterial balance, can be beneficial. The trial tests the BioNourish system, including a vulvar wash, moisturizing gel, and probiotic suppository, as part of the experimental arm. These products aim to support a healthy vaginal environment and may reduce UTI frequency. Initial evidence supports the system's potential to improve vaginal health and decrease UTI recurrence. ^{1 4 5 6 7}

Who Is on the Research Team?

Helen Cohen, MS, RN, WHNP-BC

Principal Investigator

ChristianaCare

Are You a Good Fit for This Trial?

This trial is for post-menopausal women in good health who have had at least 2 UTIs in the last six months or 3 in the past year. They must be over 12 months since their last period, which can be due to natural or medical reasons. Women with immune issues, allergies to BioNourish® ingredients, recent medical changes, pessary use, catheter reliance, or certain bladder conditions cannot join.

Inclusion Criteria

I have had at least 2 UTIs in the last 6 months or 3 in the last year, with one confirmed by a lab test.

I am a post-menopausal woman in good health, even with controlled chronic conditions.

Exclusion Criteria

I regularly use a catheter.

Women who use a pessary.

I have had changes in my treatment or procedures in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Flourish HEC Vaginal Care System for six months, including a vulvar wash, vaginal moisturizing gel, and a vaginal homeopathic suppository with probiotics

6 months

Baseline, 3 months, and 6 months assessments

Follow-up

Participants are monitored for changes in vaginal pH, microbiome composition, and frequency of UTIs

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BioNourish

Trial Overview The study tests if an over-the-counter vaginal hygiene system called BioNourish can help reduce recurrent urinary tract infections by improving the vaginal microbiome in menopausal women.

How Is the Trial Designed?

Group I: Flourish HEC Experimental Treatment 1 Intervention

The experimental (or intervention) arm uses 3 products in a vaginal hygiene system in addition to any routine care they would normally receive. These 3 products are a vulvar wash (for external use), a vaginal moisturizing gel (BioNourish), and a vaginal homeopathic suppository with probiotics. The vulvar wash is used daily or as often as a participant bathes/showers. The vaginal moisturizing gel, which is formulated to match healthy vaginal secretions for pH, osmolality, and lactic acid levels, is used every day before bed. The vaginal homeopathic suppository with probiotics is used every 3rd day before bed. This suppository contains native vaginal probiotic species associated with healthy vaginal microbiomes.

Group II: Routine Care Active Control 1 Intervention

The Routine Care arm is a control group receiving no study intervention. They receive whatever routine care is standard for the study PI's treatment of usual recurrent UTI patients, including antibiotics for active infections, estrogen and supplements for prevention of infection.

Who Is Running the Clinical Trial?

Vaginal Biome Science

Lead Sponsor

Trials

10

Recruited

3,400+

Sexual Health and Wellness Institute

Lead Sponsor

Trials

9

Recruited

170+

ChristianaCare

Collaborator

Trials

4

Recruited

10,700+

ChristianaCare

Collaborator

Trials

4

Recruited

10,700+

Published Research Related to This Trial

Probiotics, defined as live microorganisms that provide health benefits, show promise in maintaining female urogenital health and could be effective in treating conditions like recurrent bacterial vaginosis and urinary tract infections.

Recent research supports the use of specific probiotic strains that meet WHO guidelines, indicating a shift in medical perceptions towards probiotics as a credible treatment option for urogenital infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The rationale for probiotics in female urogenital healthcare. Reid, G., Burton, J., Devillard, E.[2018]

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]

There is strong scientific evidence supporting the use of cranberries to help prevent urinary tract infections by reducing E. coli adhesion to bladder cells.

Lactobacillus strains, particularly L. rhamnosus GR-1 and L. fermentum RC-14, have been shown to effectively colonize the intestine and vagina, thereby lowering the risk of intestinal and urogenital infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of cranberry and probiotics in intestinal and urogenital tract health. Reid, G.[2019]

Urogenital infections like yeast vaginitis, bacterial vaginosis, and urinary tract infections are common among women and often recur despite antimicrobial treatments, leading to frustration and diminished quality of life.

Probiotics, which are beneficial live microorganisms, are gaining acceptance as a potential alternative or supplement to traditional antimicrobial therapies, as they may help restore healthy microbial balance in the intestinal and urogenital flora.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urogenital infections in women: can probiotics help? Reid, G., Bruce, AW.[2019]

Probiotic microorganisms, particularly strains of Lactobacillus, may play a beneficial role in preventing urinary tract infections (UTIs) in women, as they are predominant in the vaginal secretions that help maintain a healthy microbiota.

Given that 40-50% of women experience cystitis in their lifetime, developing effective probiotic products could provide a preventive strategy against UTIs caused primarily by Escherichia coli.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of estrogen administration on the colonization capability of lactobacilli and Escherichia coli in the urinary tracts of mice. Silva, C., Rey, R., Elena Nader-Macías, M.[2009]

In a study of 40 women with chronic cystitis, those who received the dietary supplement Uroprofit alongside fosfomycin showed faster improvement in symptoms and laboratory results compared to those who received fosfomycin alone.

Uroprofit demonstrated antimicrobial and anti-inflammatory effects, improved bladder microcirculation, and may help prevent future relapses of chronic cystitis, making it a valuable addition to treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effectiveness of Uroprofit in women with chronic cystitis]. Neimark, AI., Neimark, BA., Nozdrachev, NA., et al.[2019]

In a clinical trial with 28 women, Lactobacillus vaginal suppositories significantly reduced the number of recurrent cystitis episodes, achieving an 86% effective response during the year of use.

The protective effects of the Lactobacillus suppositories persisted for up to a year after treatment, with no reported adverse events, indicating both safety and long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Lactobacillus vaginal suppositories for the prevention of recurrent cystitis: A phase II clinical trial. Sadahira, T., Wada, K., Araki, M., et al.[2021]

The vagina can act as a reservoir for uropathogenic bacteria, particularly Escherichia coli, which is the leading cause of urinary tract infections (UTIs).

Certain vaginal bacteria, often overlooked as uropathogens, can influence urinary health by causing injury or altering immune responses, potentially affecting UTI outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Roles of the vagina and the vaginal microbiota in urinary tract infection: evidence from clinical correlations and experimental models. Lewis, AL., Gilbert, NM.[2021]

A nutraceutical compound containing D-mannose, cranberry, and other natural ingredients significantly reduced the occurrence of recurrent urinary tract infections (UTIs) in menopausal women, with a notable decrease in patients experiencing two or more UTIs after 6 months of treatment.

At the 12-month follow-up, women using the nutraceutical reported significantly fewer UTI episodes and improved symptoms compared to those not using the treatment, highlighting its efficacy as a natural alternative to antibiotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention and treatment of cystitis during menopause: efficacy of a nutraceutical containing D-mannose, inulin, cranberry, bearberry, Olea europaea, Orthosiphon and Lactobacillus acidophilus. Mainini, G., Passaro, M., Schiattarella, A., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-infections-2023-cffa3

Vaginal Care System for Urinary Tract Infection Trial Overview The study tests if an over-the-counter vaginal hygiene system called BioNourish can help reduce recurrent urinary tract infections by improving ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05573334

Vaginal Care System for Menopausal Women With Urinary Tract ... Changes in vaginal microbiome, changes in vaginal pH, changes in symptoms of genitourinary syndrome of menopause, and frequency of UTI over the six-month study ...

3. clinicaltrial.be clinicaltrial.be/fr/details/14198?per_page=100&only_recruiting=1&only_eligible=0&only_active=0

Vaginal Care System for Menopausal Women With Urinary ... Together, these data suggest there may be a role the vaginal microbiota, particularly lactobacilli, play in maintaining urogenital health and ...

4. ctv.veeva.com ctv.veeva.com/study/effects-of-flourish-on-recurrent-urinary-tract-infection

Effects of Flourish on Recurrent Urinary Tract Infection This study will test whether women who use a commercially available, over-the-counter vaginal care system may be able to reduce recurrences of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5746606/

The Vaginal Microbiota and Urinary Tract Infection - PMC The VMB has been demonstrated to be altered at the time of UTI, in women with recurrent UTI, and following treatment of the infection, even in women without a ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05665569

Effects of Flourish HEC Vaginal Care System on Birth ... The goal of this clinical trial is to learn about how the vaginal microbiome affects pelvic floor disorders in women who have recently given birth.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05573334/vaginal-care-system-for-menopausal-women-with-urinary-tract-infections

Vaginal Care System for Menopausal Women With Urinary ... Because the vagina is close to the urethra, this vaginal microbiome shift contributes to a loss of protection against urinary tract infections ( ...