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Behavioural Intervention
Flourish for Urinary Tract Infections
N/A
Waitlist Available
Led By Brooke Faught, DNP
Research Sponsored by Vaginal Biome Science
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months to 6 months
Awards & highlights
Study Summary
This trial is testing a vaginal care system to see if it can help prevent UTIs in women who have had multiple UTIs in the past year.
Who is the study for?
This trial is for premenopausal cis women aged 18-52 who've had at least 2 UTIs in the last six months or three in the past year. They should be generally healthy and not using certain vaginal products, trying to get pregnant, lactating, immunosuppressed, or have had recent medical changes.Check my eligibility
What is being tested?
The study tests BioNourish from Flourish HEC as a potential preventive treatment against recurrent symptomatic urinary tract infections (UTIs) in women with a history of frequent UTIs.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to ingredients like aloe vera found in BioNourish. Since it's an over-the-counter product, other mild side effects might occur but are not specified.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
UTI recurrence
Vaginal Microbiome
Secondary outcome measures
Associations between microbes and UTI
Vaginal pH
Vulvovaginal symptoms questionnaire (VSQ) + addendum
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pilot Group: Flourish HECExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BioNourish, a component of Flourish HEC
2022
N/A
~20
Find a Location
Who is running the clinical trial?
Urology Associates, P.C., TennesseeOTHER
Vaginal Biome ScienceLead Sponsor
8 Previous Clinical Trials
160 Total Patients Enrolled
Sexual Health and Wellness InstituteLead Sponsor
8 Previous Clinical Trials
160 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Pilot Group: Flourish HEC
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applicants under 85 years of age able to join this research endeavor?
"This clinical study stipulates that only those aged 18-52 are eligible to participate."
Answered by AI
Have enrollment opportunities opened up for this clinical experiment?
"The information provided on clinicaltrials.gov suggests that this particular medical study, which was initially launched on September 26th 2022, is not presently accepting new participants. Nonetheless, there are 793 other trials currently enrolling patients in the area."
Answered by AI
Who is eligible to join this clinical research study?
"Patients must be between 18 and 52 years old, suffer from urinary tract infections, and have the ambition to partake in this study if they wish to apply. The trial will accept 20 participants in total."
Answered by AI
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