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Effects of Flourish on Recurrent Urinary Tract Infection

Primary Purpose

Urinary Tract Infections

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BioNourish, a component of Flourish HEC
Sponsored by
Vaginal Biome Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infections focused on measuring vaginal microbiome, microbiome, probiotic, lactobacillus, vulvovaginal symptoms questionnaire, vaginal pH

Eligibility Criteria

18 Years - 52 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • WISH A Place for Women

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pilot Group: Flourish HEC

Arm Description

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.

Outcomes

Primary Outcome Measures

Vaginal Microbiome
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).
Vaginal Microbiome
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).
Vaginal Microbiome
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).
UTI recurrence
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).

Secondary Outcome Measures

Associations between microbes and UTI
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.
Vaginal pH
Vaginal pH will be tested by pH strip.
Vaginal pH
Vaginal pH will be tested by pH strip.
Vaginal pH
Vaginal pH will be tested by pH strip.
Vulvovaginal symptoms questionnaire (VSQ) + addendum
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.
Vulvovaginal symptoms questionnaire (VSQ) + addendum
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.
Vulvovaginal symptoms questionnaire (VSQ) + addendum
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.

Full Information

First Posted
May 26, 2022
Last Updated
July 17, 2023
Sponsor
Vaginal Biome Science
Collaborators
Urology Associates, P.C., Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT05397782
Brief Title
Effects of Flourish on Recurrent Urinary Tract Infection
Official Title
Pilot Study: Effects of Flourish Vaginal Care System in Women With Recurrent Symptomatic Urinary Tract Infections
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vaginal Biome Science
Collaborators
Urology Associates, P.C., Tennessee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
vaginal microbiome, microbiome, probiotic, lactobacillus, vulvovaginal symptoms questionnaire, vaginal pH

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single group of women with recurrent symptomatic UTI will be studied longitudinally while using the intervention system. Results will be compared with historical controls.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pilot Group: Flourish HEC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BioNourish, a component of Flourish HEC
Intervention Description
BioNourish, one of three parts of the Flourish HEC system, is a vaginal moisturizing gel - a Class II medical device with FDA 510k clearance obtained in 2020.
Primary Outcome Measure Information:
Title
Vaginal Microbiome
Description
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).
Time Frame
Baseline to 3 months
Title
Vaginal Microbiome
Description
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).
Time Frame
Baseline to 6 months
Title
Vaginal Microbiome
Description
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).
Time Frame
3 months to 6 months
Title
UTI recurrence
Description
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).
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Associations between microbes and UTI
Description
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.
Time Frame
Baseline to 6 months.
Title
Vaginal pH
Description
Vaginal pH will be tested by pH strip.
Time Frame
Baseline to 6 months
Title
Vaginal pH
Description
Vaginal pH will be tested by pH strip.
Time Frame
Baseline to 3 months
Title
Vaginal pH
Description
Vaginal pH will be tested by pH strip.
Time Frame
3 months to 6 months
Title
Vulvovaginal symptoms questionnaire (VSQ) + addendum
Description
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.
Time Frame
Baseline
Title
Vulvovaginal symptoms questionnaire (VSQ) + addendum
Description
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.
Time Frame
3 months
Title
Vulvovaginal symptoms questionnaire (VSQ) + addendum
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Premenopausal cis women aged 18-52 who are in generally good health 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: Pregnant or trying to become pregnant Lactating Immunosuppressed Known allergies to aloe vera or to other components of Restore®, Balance or BiopHresh® Known vaginal infection other than BV or yeast infection at time of screening Women who have needed changes to medical intervention or in-office procedures in the last 3 months Women using vaginal acidifying agents or spermicides for contraception Women who wear a pessary
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brooke Faught, DNP
Organizational Affiliation
Women's Institute of Sexual Health / Urology Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
WISH A Place for Women
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Flourish on Recurrent Urinary Tract Infection

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