Effect of PreforPro® on Urinary and Vaginal Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of PreforPro® (Prebiotic and Bacteriophage) on Urinary and Vaginal Health

Conditions
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Bacterial Vaginosis, Bacterial Infections, Bacterial Vaginosis &#X7C; Vaginal &#X7C; Microbiology, Vaginal Infection

Intervention / Treatment
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* Drug: Preforpro
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blinded, randomized, placebo controlled study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PreforPro<br>Preforpro Dosage form - capsule Dosage - participants will consume one capsule per day for 2 months treatment period | Drug: Preforpro<br>* Preforpro will be investigated to improve vaginal health in women with BV.<br>|
| Placebo Comparator: Placebo<br>placebo will come in a capsule, which has to be consumed one capsule per day for 2 months treatment period | Other: Placebo<br>* Placebo capsules manufactured to look like Preforpro capsules<br>* Other names: Placebo for PreforPro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To change Nugent score in women with intermediate grade or BV | Vaginal swab is collected to determine the Nugent score, which is a The Nugent Score is a gram stain scoring system for vaginal swabs to diagnose bacterial vaginosis. Nugent scores between 7-10 is the standard diagnosis of BV and indicative of the absence of lactobacilli and a relative predominance of G. vaginalis and Mobiluncus spp. A Nugent score of 4-6 is indicative of intermediate BV. A Nugent score ≤ 3 means there is no BV. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine whether the bacteriophage can translocate from the gastrointestinal system to genitourinary system. | Urine will be analyzed to determine the amount of antibiotic resistant genes by reverse transcriptase-quantitative polymerase chain reaction (qPCR). The Faecal sample will also be analyzed to determine bacteriophage counts by qPCR. These two tests will tell us if the bacteriophage was able to translocate between the two systems. | 3 months | 
| Determine if the microbiota in the gut and urinary system change | To determine this outcome the study team will test quantify and capture E. coli isolates from a urine sample. MSU microbiota analysis will be performed on the sample, and bacteriophage counts will be determined by qPCR. | 3 months | 
| Determine change in vaginal cell exfoliation. | Vaginal swab is collected to determine the amount of epithelial cell exfoliation. | 3 months | 
| Determine whether probiotics can translocate from the gastrointestinal system to genitourinary system. | MSU microbiota analysis will be performed on the urine and faecal sample to determine the species present in both samples. | 3 months | 
| Determine change in urogenital ATP levels. | Urine sample will be collected to quantify urogenital ATP level. A luminescent assay kit (BacTiter-Glo microbial cell viability assay; Promega, WI) will be used to quantify the amount of ATP. The Synergy H4 hybrid multimode microplate reader will be used to quantify the amount of ATP. | 3 months |