Effect of Flourish HEC Vaginal Care System on BV Recurrence and the Vaginal Microbiome
Bacterial Vaginosis
About this trial
This is an interventional prevention trial for Bacterial Vaginosis focused on measuring vaginal microbiome, vaginal pH, Probiotic, Lactobacillus
Eligibility Criteria
Inclusion Criteria: Cis-gender women between ages 18 and 52 Premenopausal Clinically diagnosed with BV twice in the past six months or three times within the past year (by provider-determined criteria) Exclusion Criteria: Known allergies or sensitivities to any ingredients of the Flourish HEC Vaginal Care System Immunosuppressed or otherwise immunocompromised Vaginal infection at the start of the study other than bacterial vaginosis or yeast infection (these may be treated prior to starting the protocol) Recent (within past 3 months) use of any antibiotics except for treating BV Surgery within the past 3 months Pregnant or trying to conceive during the trial Lactating women Recent (within past 3 months) usage of any Good Clean Love® (GCL) products Sexual trauma history causing psychiatric or mental health disorders which may be triggered by questions related to vulvar or vaginal health, by pelvic exams, or self-application of vaginal products
Sites / Locations
- Dr. Catherine VanderloosRecruiting
- Haven Center for Sexual Medicine & Vulvovaginal DisordersRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Routine Care
Flourish HEC
Women with recurrent BV who are randomly assigned to the Routine Care (control) arm will undergo assessments at baseline, 12 weeks, and 24 weeks. They will be treated with appropriate antibiotics or antifungals in case of BV or yeast infection, respectively, but otherwise will not receive any treatment. They may engage in any vulvovaginal hygiene of their choosing except for using products made by Good Clean Love.
Women with recurrent BV who are randomly assigned to the Flourish HEC (intervention) arm will undergo assessments at baseline, 12 weeks, and 24 weeks. They will receive routine care as needed (see Routine Care arm). In addition, they will use the Flourish HEC Vaginal Care System regularly for the 24-week duration of the study. Briefly, they will use Balance intimate wash daily with regular bathing; BioNourish vaginal moisturizing gel every other day; and BiopHresh homeopathic vaginal suppository with probiotics every 3rd day. They will use no other products (except menstrual hygiene products) in the vulvovaginal area during the study.