Effect of PreforPro® on Urinary and Vaginal Health

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jeremy Burton
• Collaborators: Deerland Enzymes; Lawson Health Research Institute; St. Joseph's Health Care London

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