Effect of PreforPro® on Urinary and Vaginal Health

Launched by JEREMY BURTON · Oct 19, 2022

Keywords

ClinConnect Summary

This clinical trial is looking into how a product called PreforPro® can help improve urinary and vaginal health, particularly for women dealing with bacterial vaginosis (BV), a type of vaginal infection caused by an imbalance of bacteria. The study will involve women aged 18 to 45 who are premenopausal and have specific test results indicating they have BV. Participants will need to be able to provide a clean urine sample and agree to use a reliable method of birth control during the study.

If you join this trial, you'll be part of a research effort to see if PreforPro® can make a difference in your condition. The study is not yet recruiting participants, but if you qualify, you'll have to follow guidelines regarding medications and health history, including avoiding certain treatments before the study starts. It’s important to note that women with specific health issues, such as a history of urinary problems or those undergoing certain medical therapies, will not be eligible to participate.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female
• • 18-45 years old premenopausal (period within 6 months)
• • Nugent score of 4-6 (intermediate) or 7-10 (BV)
• • Have an ability to collect a clean urine sample
• • Prescription and over the counter medication unchanged for \> 30 days prior to the study. -Participants who are taking medications as needed (PRN) may be included if they began PRN usage \>30 days prior to baseline
• • Sexually active status of the participants can be either active or inactive
• • Participants must agree to use a medically approved method of birth control (e.g. hormonal contraceptives, intrauterine devices, vasectomy/tubal ligation, barrier methods and double-barrier method) and must have negative pregnancy test results at screening and baseline
• Exclusion Criteria:
• • Faecal incontinence
• • History of urinary fistula, bladder or kidney stones, interstitial cystitis, or cystoscopic abnormalities that could be malignant
• • Neurogenic bladder
• • A history of currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy
• • Antibiotic and/or anti-fungal medication used within the last four weeks
• • Oral probiotic supplement use within 2 weeks prior the study excluding yogurt
• • Drug abuse
• • Uncontrolled psychological disorders