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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
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.
Time frame: 3 months
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.
Time frame: 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.
Time frame: 3 months
Determine change in vaginal cell exfoliation.
Vaginal swab is collected to determine the amount of epithelial cell exfoliation.
Time frame: 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.
Time frame: 3 months
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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.
Time frame: 3 months