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Effect of PreforPro® on Urinary and Vaginal Health

Sponsored by Jeremy Burton

About this trial

Last updated a year ago

Study ID

BVPFB2021

Status

Not yet recruiting

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

18-75 Years
18 to 45 Years
Female
Female

Trial Timing

Ended 23 days ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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