Clinical study
Effect of PreforPro® on Urinary and Vaginal Health
| Status | Status unconfirmed |
|---|---|
| Type | Adjacent product trial |
| Countries | Location not listed |
| Conditions studied | Bacterial Vaginosis; Bacterial Infections; Bacterial Vaginosis | Vaginal | Microbiology; Vaginal Infection |
| Study years | 2024 (estimated)–2025 (estimated) |
| Entry review | 2026-10-03 |
Participation
Check the study record or contact the study team for current recruitment and eligibility.
Study eligibility
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
Study description
This study will investigate the effects of PreforPro® (prebiotic and bacteriophages (LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae, and LL12-Myoviridae, greater \> 6.7 X 107 PFU/gram) on bacterial vaginosis.
Study registrations
| ClinicalTrials.gov | NCT05590195 |
|---|
Notes from the source review
- PreforPro oral supplement studied for bacterial vaginosis; product class separated from personalized infection therapy.
Sources and updates
Entry reviewed . This is the date of our source review, not a confirmation of availability today.
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| Study ID | nct05590195 |
|---|