Effect of PreforPro® on Urinary and Vaginal Health

Jeremy Burton

Status and phase: Not yet enrolling; Phase 3

Conditions: Bacterial Vaginosis | Vaginal | Microbiology; Vaginal Infection; Bacterial Vaginosis; Bacterial Infections

Treatments: Other: Placebo; Drug: Preforpro

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05590195

BVPFB2021

Details and patient eligibility

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.

Full description

This is a double-blinded, placebo controlled study. Each study participant will be in the study for 90 days. During the first 28 days the participants will not take study product, and will collect samples for the study in order to act as their own controls. On day 29, participants will be randomized to intervention with either PreforPro® or placebo, which they will take once daily for the remaining 62 days. There will be a total of 5 study visits during which samples will be collected, a Quality of Life questionnaire will be completed at baseline and end of study visit.

Samples for the study are: vaginal swab, faecal sample, urine sample.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

PreforPro

Experimental group

Description:

Preforpro Dosage form - capsule Dosage - participants will consume one capsule per day for 2 months treatment period

Treatment:

Drug: Preforpro

Placebo

Placebo Comparator group

Description:

placebo will come in a capsule, which has to be consumed one capsule per day for 2 months treatment period

Treatment:

Other: Placebo