Effects of Flourish on Recurrent Urinary Tract Infection

Not Applicable

Completed

• Conditions: Urinary Tract Infections
• Interventions: Device: BioNourish, a component of Flourish HEC

• Registration Number: NCT05397782
• Lead Sponsor: Vaginal Biome Science

Brief Summary

An over-the-counter vaginal care system is being tested to see if it may be effective in preventing recurrence of symptomatic urinary tract infection (UTI) in women who have had multiple UTIs within the past year.

Detailed Description

Women who have a urinary tract infection (UTI) may experience a recurrence within weeks or months of treatment. Some women may experience 8 or more UTIs in a single year, leading to multiple rounds of antibiotics, with the individual risks to organs and risk of antibiotic resistance growing with each round. Alternative methods for prevention of recurrent UTI is therefore desirable. This study will test whether women who use a commercially available, over-the-counter vaginal care system may be able to reduce recurrences of UTI over a six-month period. This is a pilot study designed to determine whether a larger randomized controlled trial in the future would be justified.

Study Timeline

• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-05-26
• Study First Posted: 2022-05-31
• Study Start: 2022-09-26
• Primary Completion: 2024-02-21
• Study Completion: 2024-02-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

Inclusion Criteria

1. Premenopausal cis women aged 18-52 who are in generally good health
2. History of at least 2 UTIs in the past six months, or three prior UTIs in the past year, documented in the medical record. At least one must be culture-proven.

Exclusion Criteria

1. Pregnant or trying to become pregnant
2. Lactating
3. Immunosuppressed
4. Known allergies to aloe vera or to other components of Restore®, Balance or BiopHresh®
5. Known vaginal infection other than BV or yeast infection at time of screening
6. Women who have needed changes to medical intervention or in-office procedures in the last 3 months
7. Women using vaginal acidifying agents or spermicides for contraception
8. Women who wear a pessary

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pilot Group: Flourish HEC	BioNourish, a component of Flourish HEC	All women in the study will use the Flourish HEC Vaginal Care System for 6 months. Flourish HEC consists of 3 products: 1) Balance, an external feminine wash; 2) BioNourish, a vaginal moisturizing gel; and 3) BiopHresh, a homeopathic vaginal suppository with probiotics. Products are pH-balanced to match healthy vaginal pH (3.5-4.5). BioNourish is formulated to be iso-osmotic with vaginal fluid. Balance and BioNourish contain lactic acid. BiopHresh contains 7 strains of lactobacilli, including Lactobacillus crispatus and other species found in healthy vaginas or shown to be effective probiotics strains.

Primary Outcome Measures

Name	Time	Method
UTI recurrence	Baseline to 6 months	Frequency of symptomatic UTI over study duration will be assessed (number of occurrences per person). UTI will be diagnosed when one or more symptoms is present (urinary urgency, frequency, sense of burning, pelvic pain, fever, flank pain) along with one or more confirming lab tests (positive culture, urine nitrites or leukocytes).
Vaginal Microbiome	3 months to 6 months	The vaginal microbiome will be assessed using next-generation sequencing (NGS) technology to assign the biome to one of 5 "community state types" (CST). The outcome will examine whether the vaginal microbiome changes from an unhealthy one (IV or III) to a healthy one (I, II, or V).

Secondary Outcome Measures

Name	Time	Method
Vulvovaginal symptoms questionnaire (VSQ) + addendum	6 months	Vulvovaginal symptoms will be assessed by questionnaire. Both the validated VSQ and additional questions not previously validated will be used. Most questions will be asked using a 4-point Likert scale (0=not at all, 4 = all the time), except those which are binary in nature.
Vaginal pH	3 months to 6 months	Vaginal pH will be tested by pH strip.
Associations between microbes and UTI	Baseline to 6 months.	Using the NGS sequencing data from primary outcomes 1, 2, and 3, statistical modeling will be used to determine if the presence of specific individual bacteria or combinations of two or more species are associated with increased frequency of UTI.

Trial Locations

Locations (1)

WISH A Place for Women; 🇺🇸 Nashville, Tennessee, United States