At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effects of Flourish HEC Vaginal Care System on Vaginal Microbiome in Women With Recurrent Bacterial Vaginosis
In Brief
A clinical study evaluating Flourish HEC Vaginal Care System for Bacterial Vaginosis. Completed, enrolled 7 participants across 1 site.
Detailed Summary
The goal of this clinical trial is to learn about the vaginal microbiome in premenopausal women with recurrent bacterial vaginosis (BV). The main questions it aims to answer are: * Does using a specific vaginal care system reduce recurrence of BV? * How does using this vaginal care system change the vaginal microbiome and pH over time? Participants will: * Have their vaginal microbiome and pH tested in several ways at three timepoints: the start of the study, 12 weeks later, and 24 weeks after the start of the study * Answer questionnaires about vulvovaginal symptoms at each of these three timepoints * Use a specific vaginal care system at home for 24 weeks, consisting of an intimate wash, a vaginal moisturizing gel, and a vaginal probiotic suppository, if assigned to the intervention group Researchers will compare the group using the vaginal care system with a control group that does not use the system to see if using the system reduces risk of BV recurrence or changes the vaginal microbiome, pH, or symptoms.
Study Details
Timeline
Interventions
BioNourish, a component of the Flourish HEC system, is a class II medical device. In addition to BioNourish, the system includes Balance intimate wash and BiopHresh homeopathic vaginal suppository with probiotics. All products are available over the counter and have been on the market for several years.