Vaginal Care System for Urinary Tract Infection

Recruiting in Palo Alto (17 mi)

Overseen by Helen Cohen, MS, RN, WHNP-BC

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Vaginal Biome Science

Disqualifiers: Immunosuppressed, Allergies, Vaginal infection, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Menopausal women have an increased risk of recurrent urinary tract infections. This is likely due in part to hormonal changes occurring during menopause. As estrogen falls, the vaginal microbiome shifts from a healthy one to a less healthy one. Because the vagina is close to the urethra, this vaginal microbiome shift contributes to a loss of protection against urinary tract infections (UTIs). The investigators are asking whether improving the vaginal microbiome using an over-the-counter vaginal hygiene system can reduce frequency of recurrent UTI in menopausal women.

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 data supports the effectiveness of the treatment BioNourish Vaginal Care System for urinary tract infections?

Research suggests that probiotics, which are good bacteria, can help maintain urogenital health and reduce the risk of infections like urinary tract infections. Additionally, cranberries have been shown to reduce the risk of E. coli bacteria sticking to bladder cells, which can help prevent urinary tract infections. ^{1 2 3 4 5}

Is the Vaginal Care System for Urinary Tract Infection safe for humans?

The safety of the Vaginal Care System, which includes probiotics like Lactobacillus strains, is supported by studies showing these probiotics are generally safe and beneficial for maintaining urogenital health. ^{2 3 4 6 7}

How is the BioNourish Vaginal Care System treatment different from other treatments for urinary tract infections?

The BioNourish Vaginal Care System is unique because it uses probiotics (live beneficial bacteria) to restore healthy vaginal and urinary tract flora, which can help prevent and treat infections without relying on antibiotics, reducing the risk of drug resistance and recurrence. ^{1 4 5 8 9}

Research Team

Helen Cohen, MS, RN, WHNP-BC

Principal Investigator

ChristianaCare

Eligibility Criteria

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.

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

Women who use a pessary.

Trial Timeline

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

Treatment Details

Interventions

• BioNourish (Behavioural Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

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

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

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The effectiveness of Uroprofit in women with chronic cystitis]. [2019]

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

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

4. England pubmed.ncbi.nlm.nih.gov

Urogenital infections in women: can probiotics help? [2019]

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

The rationale for probiotics in female urogenital healthcare. [2018]

6. Poland 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. [2023]

7. Australia pubmed.ncbi.nlm.nih.gov

Efficacy of Lactobacillus vaginal suppositories for the prevention of recurrent cystitis: A phase II clinical trial. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

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

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

Effects of estrogen administration on the colonization capability of lactobacilli and Escherichia coli in the urinary tracts of mice. [2009]